Alcohol DependencePhase 1NCT03548714

Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol

A Phase 1 study testing PT150 and Beverage in people with Alcohol Dependence and Alcohol Interaction, run by Pop Test Oncology LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the clinical study is to compare pharmacodynamic and safety endpoints following an alcohol challenge prior to and concurrent with PT150 (study drug) treatment. Read more about this study

Who is it for?: Ages 21 to 64 years
Conditions the study is for: Alcohol Dependence, Alcohol Interaction
What is being tested?: PT150 and Beverage
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2018to 15 Jul 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

None listed.

Who cannot join

Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for substance use disorders other than alcohol or nicotine or test positive for prescription or illegal substances. With regard to marijuana/tetrahydrocannabinols (THC), an individual must test negative at the baseline. If an individual tests positive they will be given a grace period where they will have the opportunity to return and test negative prior to being enrolled;
pregnant or nursing;
receiving HRT where their dose has not been stable for a minimum of 3 months;
use of concomitant medications (except birth control pills) or other the counter (OTC) supplements for at least 14 days or 5 half-lives (whichever is longer) before the start of the study and for the entire duration of the study. Concomitant medication use includes any prescription, OTC medications, or herbal supplements;
receiving any non-pharmacotherapy treatments or procedures for which there are precautions for taking concomitantly with PT150 and/or those that interfere with the study;
have neurological or psychiatric disorders other than Alcohol Use Disorder (AUD);

Show all 27Show fewer

history of suicide attempts and/or current suicidal ideation/plan;
have evidence of untreated or unstable medical illness including: cardiovascular, neuroendocrine, autoimmune, renal, hepatic, or active Human Immucodeficiency Virus (HIV) +, Acquired Immune Deficiency Syndrome (AIDS) infection;
have a history of medically adverse reactions to alcohol (e.g., loss of consciousness, chest pain, or epileptic seizure) or major alcohol-related medical complications requiring hospitalization (i.e., hepatitis or pancreatitis);
have contraindication(s) to take the study medications such as renal or hepatic impairment, congenital metabolic disorders, or hypersensitivity to study medication class (i.e., glucosteroid abntagonist);
have past brain injury/head trauma with current symptoms (e.g., not photophobic, dizziness etc.) or past report of loss of consciousness (LOC) for >30 minutes and/or have been blast-exposed or had LOC >1 minute and current post-concussive symptoms;
self report more than thirty days' abstinence from alcohol during the three months prior to enrollment/consent;
current signs or violence or aggression, assessed as part of the consent process;
a history of adrenal insufficiency or a plasma cortisol level of ≤ 5 microgram per deciliter (mcg/dl) at screening or intake;
participation in a pharmaceutical trial or exposure to investigational drugs within 1 month of the screening visit;
currently seeking treatment for AUD
have any other illness, condition, or use medication (psychotropic or antiretroviral), which in the opinion of the principal investigator (PI) and/or the admitting physician would preclude safe and/or successful completion of the study.
Have cortisol levels > 5 mcg/dl but < 18 mcg/dL at baseline and an ACTH stimulation test that does not rule out adrenal insufficiency. Those with cortisol levels > 5 mcg/dl but < 18 mcg/dL at baseline and cortisol levels ≥ 18 after stimulation testing can be enrolled.
Have been treated with any form of corticosteroid in the past 30 days.
Have a history of endometrial hyperplasia, endometrial cancer, uterine polyps, or unexplained vaginal bleeding.
Have uncontrolled hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg).
Have potassium levels below the normal reference range. Low serum potassium must be corrected prior to dosing in patients with abnormal baseline potassium levels.
Men taking testosterone replacement therapy.
Men or women currently interested in fertility.
Have underlying inflammatory or auto-immune disorders.
Have elevated thyroid stimulating hormone (TSH) levels.
Have diabetes.

Trial locations and contacts

1 site in 1 country.

United States1 site

Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: PT150 (Formerly ORG34517) as a Potential Treatment for Alcohol Dependence-Alcohol Interaction Study

The purpose of the clinical study is to compare pharmacodynamic and safety endpoints following an alcohol challenge prior to and concurrent with PT150 (study drug) treatment.

Read the detailed description

This study can be classified as a phase 1, single center, and drug study. This within-subjects experimental procedure will assess the effects of PT150 (900 mg qd) on the subjective effects of alcohol in non-treatment-seeking alcohol-experienced volunteers (to include military service members, veterans and/or civilians). Study duration will be six days; in-house; Day 0 (admission) until day six (final study day and day of discharge). Participants will undergo two alcohol challenges on day 1 separated by 4 hours (one with alcohol, 0.8g/kg; 16% ethanol by volume, and one with placebo beverage, 1% ethanol by volume, randomly ordered) and receive active study drug (PT150) from days 1-5 (after alcohol challenge for day 1). On day 5, the study drug dosing will be followed by two more alcohol challenges (alcohol and placebo beverage randomly ordered). Physiologic (e.g., vital signs, electrocardiogram), subjective and psychometric effects (e.g., mood, urge, craving, stimulant and sedative effects), and breath alcohol levels (BAL) will be obtained after the alcohol challenges. On day six, an electrocardiogram (ECG) will be performed, adverse events (AEs) and symptom checklist will be collected, including symptoms of adrenal insufficiency (AI), and a blood draw for electrolyte levels and cortisol will be collected in the morning followed by breakfast and discharge if laboratory tests are within normal ranges. All serious adverse events will be followed clinically until resolved or clinically stable. Pharmacodynamic and safety endpoints will be assessed during the alcohol challenge prior to, and after 5 days of PT150 treatment, when PT150 has reached steady state. For females, a follow-up visit will be scheduled to occur at least 14 days after the final dose of PT150 is administered to ensure pregnancy does not occur. The objectives of the study are to compare pharmacodynamics and safety endpoints following an alcohol challenge prior to and concurrent with PT150. Given available pre-clinical and clinical evidence for the salutatory effect of glucocorticoid receptor (GR) antagonists on alcohol withdrawal, it was hypothesized that PT150 will not significantly alter pharmacodynamic measures and will be safe and well-tolerated under conditions of alcohol consumption.

Conditions: Alcohol Dependence, Alcohol Interaction
Being tested: PT150, Beverage
Keywords: Alcohol, Alcoholic, Alcoholism, Alcohol abuse, Alcohol interaction, Alcohol Use Disorder, Alcohol use, Alcohol dependence, Alcohol dependent, Ethanol abuse, Ethanol use
Medical subject headings: Alcoholism, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PT150Drug
Also called Formerly ORG34517
Intervention 1 includes PT150 with alcohol consumption
BeverageOther
Also called Placebo drink and ethanol drink
Alcohol beverage will be prepared by an in-house pharmacist at the MEDVAMC in a volume of 450 ml for a 70 kg individual and adjusted for body weight by varying the volume. Alcohol will be administered in a concentration of 16% alcohol (Everclear, St. Louis, MO) by volume in grape Kool-Aid (Kraft Foods, Northfield, IL). Placebo will be prepared in the same manner but contain 1% alcohol to mask taste.

Study groups in NCT03548714
Study group	Role	What they receive
PT150 with alcohol consumption	Experimental	Study drug to be administered as a single, fixed dose over a 5-day period. An alcohol challenge (with ethanol or placebo beverage) will be completed on day 1 (pre-treatment), and day-5 (post-treatment), at predetermined times. Receives: Drug: PT150
PT150 with placebo consumption	Placebo comparator	Study drug to be administered as a single, fixed dose over a 5-day period. An alcohol challenge (with ethanol or placebo beverage) will be completed on day 1 (pre-treatment), and day-5 (post-treatment), at predetermined times. Receives: Other: Beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Breath-alcohol levels (BALs) - Cmax
Mean estimates of Cmax (observed maximum concentration after alcohol challenge) will be calculated and compared from post-alcohol challenge pre-treatment (day 1) to post alcohol challenge with concurrent treatment (day 5).
Measured: from post-alcohol challenge pre-treatment (day 1)to post alcohol with concurrent intreatment (day 5)
Change in Breath-alcohol levels (BALs) - Tmax
Mean estimates of Tmax (time of occurrence of Cmax) will be calculated and compared from post-alcohol challenge pre-treatment (day 1) to post alcohol challenge with concurrent treatment (day 5).
Measured: from post-alcohol challenge pre-treatment (day 1)to post alcohol with concurrent treatment (day 5)
Change in Breath-alcohol levels (BALs) - AUC
Mean estimates of AUC (area under the concentration curve through 2 hours post-alcohol challenge) will be calculated and compared from post-alcohol challenge pre-treatment (day 1) to post alcohol challenge with concurrent treatment (day 5).
Measured: from post-alcohol challenge pre-treatment (day 1) to post alcohol with concurrent treatment (day 5)
Change in blood pressure
For each alcohol challenge on Days 1 and 5, the change in blood pressure (systolic and diastolic) is computed as the difference in blood pressure measurements taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Heart Rate (Pulse)
For each alcohol challenge on days 1 and 5, the change in heart rate (pulse) is computed as the difference in heart rate measurements taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5).
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in ECG abnormalities
ECG abnormalities (normal, abnormal but not clinically significant, clinically significant abnormal) will be compared between pre-treatment (baseline, day 1 AM) to post-treatment (days 1 through 6)
Measured: from pre-treatment (baseline) to post-treatment (day 6)
Change in Positive Affect score from the Positive and Negative Affect Schedule (PANAS)
Positive changes in Positive Affect score indicate an increased positive affect. For each alcohol challenge on Days 1 and 5, the change in the positive affect scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Negative Affect score from the Positive and Negative Affect Schedule (PANAS)
Negative changes in Negative Affect score indicate a decreased negative effect post-challenge. For each alcohol challenge on Days 1 and 5, the change in the negative affect scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Alcohol Urge Questionnaire (AUQ) score
The change in AUQ score reflects the participant's thoughts and feelings about drinking, with negative score changes indicating a decrease in craving post-challenge. For each alcohol challenge on Days 1 and 5, the change in the AUQ scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Biphasic Alcohol Effects Scale (BAES) Sedative effects
: The change in BAES sedative effects measures the sedative effects of alcohol, with a positive score change indicating an increase in sedation. For each alcohol challenge on Days 1 and 5, the change in the BAES sedative effects scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Biphasic Alcohol Effects Scale (BAES) Stimulant effects
The change in BAES stimulant effects measures the stimulant effects of alcohol, with a positive score change indicating an increase in stimulation. For each alcohol challenge on Days 1 and 5, the change in the BAES stimulant effects scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - Pentobarbital-Chlorpromazine-Alcohol Group Scale
The Pentobarbital-Chlorpromazine-Alcohol Group (PCAG) Scale of the ARCI assesses the subjective effects of those psychologically active drugs, with positive score changes indicating an increase in sedation. For each alcohol challenge on Days 1 and 5, the change in the ARCI PCAG scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - Amphetamine Scale
The Amphetamine Scale of the ARCI assesses the subjective effects of that psychologically active drug, with positive score changes indicating an increase in stimulation. For each alcohol challenge on Days 1 and 5, the change in the ARCI amphetamine scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - Morphine-Benzedrine Group (MBG) Scale
The Morphine-Benzedrine Group Scale of the ARCI assesses the subjective effects of those psychologically active drugs, with positive score changes indicating an increase in euphoria/mood elevation. For each alcohol challenge on Days 1 and 5, the change in the ARCI MBG scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - LSD Scale
The LSD Scale of the ARCI assesses the subjective effects of that psychologically active drug, with positive score changes indicating an increase in dysphoric and psychotomimetic changes. For each alcohol challenge on Days 1 and 5, the change in the ARCI LSD scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - Benzedrine Group Scale
The Benzedrine Group Scale of the ARCI assesses the subjective effects of those psychologically active drugs, with positive score changes indicating an increase in intellectual efficiency and energy. For each alcohol challenge on Days 1 and 5, the change in the ARCI Benzedrine scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Measured: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Differences in the adverse events
Number of adverse events on day 1 (pre-treatment) will be compared to the number of adverse events on Day 5 (post-treatment). Proportion of patients experiencing an adverse event on day 1 (pre-treatment) may also be compared to the proportion of patients experiencing an adverse event on day 5 (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)

Secondary outcomes (14)

Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Total Recall Score
. Change in cognitive effects, measured by the HVLT-R Total Recall scores, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge day 5 (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Delayed Recall Score
. Change in cognitive effects, measured by the HVLT-R Delayed Recall scores, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge day 5 (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Percent Retained Score
. Change in cognitive effects, measured by the HVLT-R Percent Retained scores, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge day 5 (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Discrimination Index Score
. Change in cognitive effects, measured by the HVLT-R Discrimination Index scores, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge day 5 (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Dual n-Back (DNB) auditory trial accuracy score
Change in cognitive effects, measured by the DNB auditory trial accuracy scores, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Dual n-Back (DNB) visual trial accuracy score
Change in cognitive effects, measured by the DNB visual trial accuracy scores, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Dual n-Back (DNB) auditory reaction time
Change in cognitive effects, measured by the DNB auditory reaction times, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Dual n-Back (DNB) visual reaction time
Change in cognitive effects, measured by the DNB visual reaction time, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Continuous Performance Task-2 (CPT) errors of commission score
Change in cognitive effects, measured by the CPT errors of commission score, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Continuous Performance Task-2 (CPT) errors of ommission score
Change in cognitive effects, measured by the CPT errors of ommission score, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Continuous Performance Task-2 (CPT) errors of perseveration score
Change in cognitive effects, measured by the CPT errors of perseveration score, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Continuous Performance Task-2 (CPT) reaction time
Change in cognitive effects, measured by the CPT reaction time, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Psychomotor Assessment - One Legged Stand (OLS)
Change in psychomotor effects, measured by the OLS, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)
Psychomotor Assessment - Walk and Turn (WAT)
Change in psychomotor effects, measured by the WAT, will be compared between the day 1 alcohol challenge (pre-treatment) and the day 5 alcohol challenge (post-treatment).
Measured: from pre-treatment (day 1) to post-treatment (day 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201815 Jul 2019

First posted7 Jun 2018
Study start1 Sep 2018
Primary completion15 Jul 2019
Study completion15 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Alcohol DependenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Apart from the Research Pharmacists, all others engaged with this study (participants and study team) will be masked to alcohol challenge order.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03548714
Sponsor's protocol ID: AS140026-A3.b
Other IDs: W81XWH-15-2-0077
Status last verified: Aug 2019
First submitted: 10 May 2018
Last updated: 22 Aug 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Data will be shared with a registry per the data sharing plans of the Consortium.

Publications

Reynolds AR, Saunders MA, Brewton HW, Winchester SR, Elgumati IS, Prendergast MA. Acute oral administration of the novel, competitive and selective glucocorticoid receptor antagonist ORG 34517 reduces the severity of ethanol withdrawal and related hypothalamic-pituitary-adrenal axis activation. Drug Alcohol Depend. 2015 Sep 1;154:100-4. doi: 10.1016/j.drugalcdep.2015.06.018. Epub 2015 Jun 22.
PubMed 26143299
Vendruscolo LF, Estey D, Goodell V, Macshane LG, Logrip ML, Schlosburg JE, McGinn MA, Zamora-Martinez ER, Belanoff JK, Hunt HJ, Sanna PP, George O, Koob GF, Edwards S, Mason BJ. Glucocorticoid receptor antagonism decreases alcohol seeking in alcohol-dependent individuals. J Clin Invest. 2015 Aug 3;125(8):3193-7. doi: 10.1172/JCI79828. Epub 2015 Jun 29.
PubMed 26121746
Morice C, Baker DG, Patel MM, Nolen TL, Nowak K, Hirsch S, Kosten TR, Verrico CD. A randomized trial of safety and pharmacodynamic interactions between a selective glucocorticoid receptor antagonist, PT150, and ethanol in healthy volunteers. Sci Rep. 2021 May 10;11(1):9876. doi: 10.1038/s41598-021-88609-6.
PubMed 33972573

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PT150 (Formerly ORG34517) as a Potential Treatment for Alcohol Dependence-Alcohol Interaction Study
ClinicalTrials.gov ID: NCT03548714
Acronym / sponsor ID: AS140026-A3.b
Conditions: Alcohol Dependence, Alcohol Interaction
Keywords: Alcohol, Alcoholic, Alcoholism, Alcohol abuse, Alcohol interaction, Alcohol Use Disorder, Alcohol use, Alcohol dependence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Pop Test Oncology LLCIndustry (pharma, biotech, devices)
Collaborators: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, Congressionally Directed Medical Research Programs, Michael E. DeBakey VA Medical Center, Baylor College of Medicine, University of California, San Diego
Study start: 1 Sep 2018 (actual)
Primary completion: 15 Jul 2019 (actual)
Study completion: 15 Jul 2019 (actual)
First posted: 7 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the clinical study is to compare pharmacodynamic and safety endpoints following an alcohol challenge prior to and concurrent with PT150 (study drug) treatment.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Apart from the Research Pharmacists, all others engaged with this study (participants and study team) will be masked to alcohol challenge order.

Arm	Type	Receives
PT150 with alcohol consumption	Experimental	Drug: PT150Study drug to be administered as a single, fixed dose over a 5-day period. An alcohol challenge (with ethanol or placebo beverage) will be completed on day 1 (pre-treatment), and day-5 (post-treatment), at predetermined times.
PT150 with placebo consumption	Placebo comparator	Other: BeverageStudy drug to be administered as a single, fixed dose over a 5-day period. An alcohol challenge (with ethanol or placebo beverage) will be completed on day 1 (pre-treatment), and day-5 (post-treatment), at predetermined times.

Who may qualify

Ages: 21 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (27 listed)

Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for substance use disorders other than alcohol or nicotine or test positive for prescription or illegal substances. With regard to marijuana/tetrahydrocannabinols (THC), an individual must test negative at the baseline. If an individual tests positive they will be given a grace period where they will have the opportunity to return and test negative prior to being enrolled;
pregnant or nursing;
receiving HRT where their dose has not been stable for a minimum of 3 months;
use of concomitant medications (except birth control pills) or other the counter (OTC) supplements for at least 14 days or 5 half-lives (whichever is longer) before the start of the study and for the entire duration of the study. Concomitant medication use includes any prescription, OTC medications, or herbal supplements;
receiving any non-pharmacotherapy treatments or procedures for which there are precautions for taking concomitantly with PT150 and/or those that interfere with the study;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PT150Also: Formerly ORG34517Intervention 1 includes PT150 with alcohol consumption	Drug	PT150 with alcohol consumption
BeverageAlso: Placebo drink and ethanol drinkAlcohol beverage will be prepared by an in-house pharmacist at the MEDVAMC in a volume of 450 ml for a 70 kg individual and adjusted for body weight by varying the volume. Alcohol will be administered in a concentration of 16% alcohol (Everclear, St. Louis, MO) by volume in grape Kool-Aid (Kraft Foods, Northfield, IL). Placebo will be prepared in the same manner but contain 1% alcohol to mask taste.	Other	PT150 with placebo consumption

Primary outcome

Change in Breath-alcohol levels (BALs) - Cmax
Time frame: from post-alcohol challenge pre-treatment (day 1)to post alcohol with concurrent intreatment (day 5)
Mean estimates of Cmax (observed maximum concentration after alcohol challenge) will be calculated and compared from post-alcohol challenge pre-treatment (day 1) to post alcohol challenge with concurrent treatment (day 5).
Change in Breath-alcohol levels (BALs) - Tmax
Time frame: from post-alcohol challenge pre-treatment (day 1)to post alcohol with concurrent treatment (day 5)
Mean estimates of Tmax (time of occurrence of Cmax) will be calculated and compared from post-alcohol challenge pre-treatment (day 1) to post alcohol challenge with concurrent treatment (day 5).
Change in Breath-alcohol levels (BALs) - AUC
Time frame: from post-alcohol challenge pre-treatment (day 1) to post alcohol with concurrent treatment (day 5)
Mean estimates of AUC (area under the concentration curve through 2 hours post-alcohol challenge) will be calculated and compared from post-alcohol challenge pre-treatment (day 1) to post alcohol challenge with concurrent treatment (day 5).
Change in blood pressure
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
For each alcohol challenge on Days 1 and 5, the change in blood pressure (systolic and diastolic) is computed as the difference in blood pressure measurements taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Heart Rate (Pulse)
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
For each alcohol challenge on days 1 and 5, the change in heart rate (pulse) is computed as the difference in heart rate measurements taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5).
Change in ECG abnormalities
Time frame: from pre-treatment (baseline) to post-treatment (day 6)
ECG abnormalities (normal, abnormal but not clinically significant, clinically significant abnormal) will be compared between pre-treatment (baseline, day 1 AM) to post-treatment (days 1 through 6)
Change in Positive Affect score from the Positive and Negative Affect Schedule (PANAS)
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Positive changes in Positive Affect score indicate an increased positive affect. For each alcohol challenge on Days 1 and 5, the change in the positive affect scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Negative Affect score from the Positive and Negative Affect Schedule (PANAS)
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Negative changes in Negative Affect score indicate a decreased negative effect post-challenge. For each alcohol challenge on Days 1 and 5, the change in the negative affect scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Alcohol Urge Questionnaire (AUQ) score
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
The change in AUQ score reflects the participant's thoughts and feelings about drinking, with negative score changes indicating a decrease in craving post-challenge. For each alcohol challenge on Days 1 and 5, the change in the AUQ scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Biphasic Alcohol Effects Scale (BAES) Sedative effects
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
: The change in BAES sedative effects measures the sedative effects of alcohol, with a positive score change indicating an increase in sedation. For each alcohol challenge on Days 1 and 5, the change in the BAES sedative effects scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Biphasic Alcohol Effects Scale (BAES) Stimulant effects
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
The change in BAES stimulant effects measures the stimulant effects of alcohol, with a positive score change indicating an increase in stimulation. For each alcohol challenge on Days 1 and 5, the change in the BAES stimulant effects scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - Pentobarbital-Chlorpromazine-Alcohol Group Scale
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
The Pentobarbital-Chlorpromazine-Alcohol Group (PCAG) Scale of the ARCI assesses the subjective effects of those psychologically active drugs, with positive score changes indicating an increase in sedation. For each alcohol challenge on Days 1 and 5, the change in the ARCI PCAG scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - Amphetamine Scale
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
The Amphetamine Scale of the ARCI assesses the subjective effects of that psychologically active drug, with positive score changes indicating an increase in stimulation. For each alcohol challenge on Days 1 and 5, the change in the ARCI amphetamine scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - Morphine-Benzedrine Group (MBG) Scale
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
The Morphine-Benzedrine Group Scale of the ARCI assesses the subjective effects of those psychologically active drugs, with positive score changes indicating an increase in euphoria/mood elevation. For each alcohol challenge on Days 1 and 5, the change in the ARCI MBG scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - LSD Scale
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
The LSD Scale of the ARCI assesses the subjective effects of that psychologically active drug, with positive score changes indicating an increase in dysphoric and psychotomimetic changes. For each alcohol challenge on Days 1 and 5, the change in the ARCI LSD scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Change in Addiction Research Center Inventory (ARCI) score - Benzedrine Group Scale
Time frame: from post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
The Benzedrine Group Scale of the ARCI assesses the subjective effects of those psychologically active drugs, with positive score changes indicating an increase in intellectual efficiency and energy. For each alcohol challenge on Days 1 and 5, the change in the ARCI Benzedrine scale scores are computed as the difference in scores taken during the 2 hours after the alcohol challenges on days 1 and 5 and the ones collected immediately prior to that alcohol challenge. Mean changes are then calculated and compared from both post-alcohol challenge pre-treatment (day 1) to post-alcohol challenge with concurrent treatment (day 5)
Differences in the adverse events
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Number of adverse events on day 1 (pre-treatment) will be compared to the number of adverse events on Day 5 (post-treatment). Proportion of patients experiencing an adverse event on day 1 (pre-treatment) may also be compared to the proportion of patients experiencing an adverse event on day 5 (post-treatment).

14 secondary outcomes

Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Total Recall Score
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Delayed Recall Score
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Percent Retained Score
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Discrimination Index Score
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Dual n-Back (DNB) auditory trial accuracy score
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Dual n-Back (DNB) visual trial accuracy score
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Dual n-Back (DNB) auditory reaction time
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Dual n-Back (DNB) visual reaction time
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Continuous Performance Task-2 (CPT) errors of commission score
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Continuous Performance Task-2 (CPT) errors of ommission score
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Continuous Performance Task-2 (CPT) errors of perseveration score
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Cognitive Assessment - Continuous Performance Task-2 (CPT) reaction time
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Psychomotor Assessment - One Legged Stand (OLS)
Time frame: from pre-treatment (day 1) to post-treatment (day 5)
Psychomotor Assessment - Walk and Turn (WAT)
Time frame: from pre-treatment (day 1) to post-treatment (day 5)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
Background: PubMed 26143299Reynolds AR, Saunders MA, Brewton HW, Winchester SR, Elgumati IS, Prendergast MA. Acute oral administration of the novel, competitive and selective glucocorticoid receptor antagonist ORG 34517 reduces the severity of ethanol withdrawal and related hypothalamic-pituitary-adrenal axis activation. Drug Alcohol Depend. 2015 Sep 1;154:100-4. doi: 10.1016/j.drugalcdep.2015.06.018. Epub 2015 Jun 22.
Background: PubMed 26121746Vendruscolo LF, Estey D, Goodell V, Macshane LG, Logrip ML, Schlosburg JE, McGinn MA, Zamora-Martinez ER, Belanoff JK, Hunt HJ, Sanna PP, George O, Koob GF, Edwards S, Mason BJ. Glucocorticoid receptor antagonism decreases alcohol seeking in alcohol-dependent individuals. J Clin Invest. 2015 Aug 3;125(8):3193-7. doi: 10.1172/JCI79828. Epub 2015 Jun 29.
Derived from this study: PubMed 33972573Morice C, Baker DG, Patel MM, Nolen TL, Nowak K, Hirsch S, Kosten TR, Verrico CD. A randomized trial of safety and pharmacodynamic interactions between a selective glucocorticoid receptor antagonist, PT150, and ethanol in healthy volunteers. Sci Rep. 2021 May 10;11(1):9876. doi: 10.1038/s41598-021-88609-6.
Individual participant dataSharing planned: Yes. Data will be shared with a registry per the data sharing plans of the Consortium.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PT150 and Beverage in people with Alcohol Dependence and Alcohol Interaction, run by Pop Test Oncology LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Breath-alcohol levels (BALs) - Cmax (time frame: from post-alcohol challenge pre-treatment (day 1)to post alcohol with concurrent intreatment (day 5)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03548714, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.