Alcohol DependencePhase 1/2SPADNCT01842503

Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent

A Phase 1/2 study testing GET 73 and inactive ingredients capsule in people with Alcohol Dependence, run by Laboratorio Farmaceutico Ct S.r.l. 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

Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics (intoxication and sedation)and safety profile in alcohol-dependent individuals.To evaluate whether GET 73, as compared to placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink during the cue… Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Alcohol Dependence
What is being tested?: GET 73 and inactive ingredients capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Nov 2014to Nov 2018
Phase: Phase 1/2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

male or female subjects, between 21 and 65 years old (inclusive);
participants must meet criteria for current Diagnostic and Statistical Manual (DSM-IV)diagnosis of alcohol dependence,supported by the structured clinical interview for DSM-IV Axis I Disorders Patient Edition;
participants must meet criteria for heavy drinking, defined as averaging
4 drinks/day for women and ≥5 drinks/day for men during a 30-day period within the 90 days prior to screening evaluation;
participants must be in good health as confirmed by medical history, physical examination, ECG, lab tests;
females must be postmenopausal for at least one year or surgically sterile. Otherwise, females will be excluded (even if they are using any kind of birth control). Proof (medical records, certification from an medical doctor) of surgical sterility will be required. Certification of postmenopausal for at least 1 year and postmenopausal levels of FSH will also be required to be into the study;
participants must be willing to take oral medication and adhere to the study procedures;
participants must give their consent to enter the study by signing the informed consent form.

Who cannot join

individuals seeking treatment for alcohol dependence;
positive urine drug screen at baseline for positive drug screen for the following: opioids, benzodiazepines, cocaine, methamphetamine or any other stimulants. A urine drug screen may be repeated once and must test negative before randomization;
individuals diagnosed with a current substance dependence, other than alcohol or nicotine;
meet DSM-IV Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar disorder, or other psychoses;
Subjects taking any psychoactive medication that in the opinion of the subjects primary care physician, cannot be discontinued at least 14 days prior to being randomized;
an active illness within the past 6 months of Visit 1 that meet the DSM-IV criteria for a diagnosis of Major Depressive Disorder or Anxiety Disorder;

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subjects with a history of suicide attempts and/or at risk for suicide will be excluded, based on the Structured Clinical Interview Disorders assessment and on the Investigators' evaluation;
clinically significant medical abnormalities (i.e., unstable hypertension, clinically significant abnormal ECG, bilirubin > 150% of the upper normal limit, alanine aminotransferase or aspartate aminotransferase elevations >300% the upper normal limit, estimated creatinine clearance ≤ 60 dl/min);
current use of any medications prescribed to reduce alcohol use e.g. naltrexone, acamprosate, disulfiram or topiramate;
concomitant use of cytochromeP450 2C19 substrates; assumption of cytochromeP450 2C19 and cytochromeP450 3A4 inhibitors or inducers in the 14 days before dosing;
individuals with a reasonable expectation of being institutionalized during the course of the trial;
participants who have significant alcohol withdrawal symptoms, defined as a Clinical Institute Withdrawal Assessment >10;
history of seizures (e.g. epilepsy), including alcohol-related seizures;
history of delirium tremens;
subjects who have participated in any behavioral and/or pharmacological study within the past 30 days;
history of delirium tremens.

Trial locations and contacts

1 site in 1 country.

United States1 site

Roger Williams Medical Center
Providence, Rhode Island, 02908

Other trials in United States

About this study

Official title: A Phase 1b/2a, Cross-over, Randomised, Double-blind, Placebo Controlled Study to Investigate the Safety and Pharmacodynamic Effects of GET 73 in Alcohol Dependent Subjects

Conditions: Alcohol Dependence
Being tested: GET 73, inactive ingredients capsule
Keywords: alcohol dependence, cue reactivity, alcohol self administration
Medical subject headings: Alcoholism

What participants receive

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

GET 73Drug
300 mg tid on 3 days cycle
inactive ingredients capsuleDrug
3 capsules tid on 3 days cycle

Study groups in NCT01842503
Study group	Role	What they receive
GET 73	Active comparator	300 mg (3 capsules) tid for 3 days Receives: Drug: GET 73
inactive ingredients capsule	Placebo comparator	3 capsules tid for 3 days Receives: Drug: inactive ingredients capsule

What is being measured

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

changes in area under the plasma concentration of alcohol versus time curve (AUC), after administration of GET 73 or placebo
On Day 2 and Day 12 subjects have an indwelling catheter placed in a forearm vein for blood draws. After the 5th dose of GET 73 or placebo is administered on Day 2 and Day 12, participants receive a dose of alcohol 30 minutes later, which is calculated to produce a peak of 0.08 g/L, based on body water content.
AUC will be evaluated as mean value of overall subjects evaluated
Measured: blood samples are drawn on day 2 and day 12 at baseline and then, following the start of alcohol consumption, for the next 8 hours or until the blood alcohol level is zero on 2 successive determinations
Changes in pleasurable and negative effects of alcohol intoxication and sedation, measured by the Biphasic Alcohol Effects Scales (BAES),during the Alcohol Self-Administration (ASA) session, when taking GET 73 compared to placebo.
Measured: The BAES will be administered, at Day 2 and Day 12, eight times after the priming drink is presented during the ASA.
Changes in reaction time, measured by Conners's Continuous Performance Task (CPT),when taking GET 73 compared to placebo
Measured: CPT will be assessed at Day 2 and Day 12
Changes in cognitive performance, measured by Digit Symbol Substitution Test (DSST), when taking GET 73 compared to placebo
Measured: DSST will be assessed at Day 2 and Day 12
Frequency of adverse events (AEs) occured after placebo or GET 73 administration
All AEs occurring during the study will be recorded. Subjects are discharged from the hospital at Day 13, after the two inpatient treatment phases (Day 1-Day 3 and Day 11-Day 13). A follow-up visit, approximately from 7 to 14 days after the second CR/ASA experiment, will be performed. The AEs will be grouped by Medical Dictionary for Regulatory Affairs preferred terms into frequency tables according to system organ class (SOC).
Frequencies of AEs occurred after placebo or GET 73 administration will be compared using chi-square or Fischer's exact test.
Measured: up to 20-27 days
Changes in cue reactivity (CR) responses to alcohol cues, in terms of urge to drink, as measured by the Alcohol Urge Questionnaire (AUQ), when taking GET 73 compared to placebo.
To evaluate whether GET 73, as compared to placebo, results in reductions in craving (as measured by the AUQ), the AUQ will be administered eight times after the priming drink is presented during the ASA.
Measured: At Day 3 and Day 13 during the two treatment phases
Changes in CR responses to alcohol cues, in terms of psychophysiological responses,heart rate,mean arterial pressure and salivation changes during the CR session.
There are three experimental time periods of 3-minutes each during each CR session. Cotton swabs will be weighed at the end of each 3-minute block and the mean values for weight of salivation will be calculated. An average heart rate and an average mean arterial pressure will be calculated for each of these three time periods.
Measured: At Day 3 and Day 13 during the two treatment phases
Changes in attention to the sight and smell of cues, as measured by Alcohol Attention Scale (AAS), during the CR.
Measured: This endpoint will be measured twice in each CR session (Day 3 and Day 13) through the AAS.
Effects of GET 73 on the amount of alcohol consumed during the ASA. The maximum quantity of alcohol will be taken, to have a measure directly comparable to AUQ results
Measured: At Day 3 and Day 13 during the two treatment phases
Changes in peak plasma concentration (Cmax) of alcohol after administration of GET 73 or placebo
Cmax will be calculated at the peak level as mean value of overall subjects evaluated
Measured: blood samples are drawn on Day 2 and Day 12 at baseline and then, following the start of alcohol consumption, for the next 8 hours or until the blood alcohol level is zero on 2 successive determinations
Changes in time to peak plasma level (Tmax) of alcohol after administration of GET 73 or placebo
Tmax will be evaluated as the time after administration corresponding to the time of peak plasma level and as mean value of overall subjects evaluated
Measured: blood samples are drawn on Day 2 and Day 12 at baseline and then, following the start of alcohol consumption, for the next 8 hours or until the blood alcohol level is zero on 2 successive determinations
Changes in half-life of alcohol after administration of GET 73 or placebo
Half-life will be calculated as mean value of overall subjects evaluated
Measured: blood samples are drawn on Day 2 and Day 12 at baseline and then, following the start of alcohol consumption, for the next 8 hours or until the blood alcohol level is zero on 2 successive determinations
Characteristics of adverse events (AEs) occured after placebo or GET 73 administration
All AEs occurring during the study will be recorded. Subjects are discharged from the hospital at Day 13, after the two inpatient treatment phases (Day 1-Day 3 and Day 11-Day 13). A follow-up visit, approximately from 7 to 14 days after the second CR/ASA experiment, will be performed. The AEs will be grouped by Medical Dictionary for Regulatory Affairs preferred terms according to system organ class (SOC). When an AE occurs more than once for a subject, the maximal severity and strongest relationship to the medication will be counted.
Characteristics of AEs occurred after placebo or GET 73 administration will be compared using chi-square or Fischer's exact test.
Measured: up to 20-27 days

Timeline

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

Nov 2014Nov 2018

First posted29 Apr 2013 (estimated)
Study startNov 2014
Primary completionNov 2018
Study completionNov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01842503
Sponsor's protocol ID: 73CT-2-03
Other IDs: 2012-005515-13
Acronym: SPAD
Status last verified: Apr 2019
First submitted: 20 Dec 2012
Last updated: 10 Apr 2019
Results posted: No
Data monitoring committee: No

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?

See locations

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All Alcohol Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2a, Cross-over, Randomised, Double-blind, Placebo Controlled Study to Investigate the Safety and Pharmacodynamic Effects of GET 73 in Alcohol Dependent Subjects
ClinicalTrials.gov ID: NCT01842503
Acronym / sponsor ID: SPAD / 73CT-2-03
Conditions: Alcohol Dependence
Keywords: alcohol dependence, cue reactivity, alcohol self administration
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Laboratorio Farmaceutico Ct S.r.l.Industry (pharma, biotech, devices)
Collaborators: Voisin Consulting, Inc., Latis S.r.l., Quotient Bioresearch
Study start: Nov 2014 (actual)
Primary completion: Nov 2018 (actual)
Study completion: Nov 2018 (actual)
First posted: 29 Apr 2013 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
GET 73	Active comparator	Drug: GET 73300 mg (3 capsules) tid for 3 days
inactive ingredients capsule	Placebo comparator	Drug: inactive ingredients capsule3 capsules tid for 3 days

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

male or female subjects, between 21 and 65 years old (inclusive);
participants must meet criteria for current Diagnostic and Statistical Manual (DSM-IV)diagnosis of alcohol dependence,supported by the structured clinical interview for DSM-IV Axis I Disorders Patient Edition;
participants must meet criteria for heavy drinking, defined as averaging
participants must be in good health as confirmed by medical history, physical examination, ECG, lab tests;
females must be postmenopausal for at least one year or surgically sterile. Otherwise, females will be excluded (even if they are using any kind of birth control). Proof (medical records, certification from an medical doctor) of surgical sterility will be required. Certification of postmenopausal for at least 1 year and postmenopausal levels of FSH will also be required to be into the study;

Key exclusion criteria (16 listed)

individuals seeking treatment for alcohol dependence;
positive urine drug screen at baseline for positive drug screen for the following: opioids, benzodiazepines, cocaine, methamphetamine or any other stimulants. A urine drug screen may be repeated once and must test negative before randomization;
individuals diagnosed with a current substance dependence, other than alcohol or nicotine;
meet DSM-IV Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar disorder, or other psychoses;
Subjects taking any psychoactive medication that in the opinion of the subjects primary care physician, cannot be discontinued at least 14 days prior to being randomized;

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
GET 73300 mg tid on 3 days cycle	Drug	GET 73
inactive ingredients capsule3 capsules tid on 3 days cycle	Drug	inactive ingredients capsule

Primary outcome

changes in area under the plasma concentration of alcohol versus time curve (AUC), after administration of GET 73 or placebo
Time frame: blood samples are drawn on day 2 and day 12 at baseline and then, following the start of alcohol consumption, for the next 8 hours or until the blood alcohol level is zero on 2 successive determinations
On Day 2 and Day 12 subjects have an indwelling catheter placed in a forearm vein for blood draws. After the 5th dose of GET 73 or placebo is administered on Day 2 and Day 12, participants receive a dose of alcohol 30 minutes later, which is calculated to produce a peak of 0.08 g/L, based on body water content. AUC will be evaluated as mean value of overall subjects evaluated
Changes in pleasurable and negative effects of alcohol intoxication and sedation, measured by the Biphasic Alcohol Effects Scales (BAES),during the Alcohol Self-Administration (ASA) session, when taking GET 73 compared to placebo.
Time frame: The BAES will be administered, at Day 2 and Day 12, eight times after the priming drink is presented during the ASA.
Changes in reaction time, measured by Conners's Continuous Performance Task (CPT),when taking GET 73 compared to placebo
Time frame: CPT will be assessed at Day 2 and Day 12
Changes in cognitive performance, measured by Digit Symbol Substitution Test (DSST), when taking GET 73 compared to placebo
Time frame: DSST will be assessed at Day 2 and Day 12
Frequency of adverse events (AEs) occured after placebo or GET 73 administration
Time frame: up to 20-27 days
All AEs occurring during the study will be recorded. Subjects are discharged from the hospital at Day 13, after the two inpatient treatment phases (Day 1-Day 3 and Day 11-Day 13). A follow-up visit, approximately from 7 to 14 days after the second CR/ASA experiment, will be performed. The AEs will be grouped by Medical Dictionary for Regulatory Affairs preferred terms into frequency tables according to system organ class (SOC). Frequencies of AEs occurred after placebo or GET 73 administration will be compared using chi-square or Fischer's exact test.
Changes in cue reactivity (CR) responses to alcohol cues, in terms of urge to drink, as measured by the Alcohol Urge Questionnaire (AUQ), when taking GET 73 compared to placebo.
Time frame: At Day 3 and Day 13 during the two treatment phases
To evaluate whether GET 73, as compared to placebo, results in reductions in craving (as measured by the AUQ), the AUQ will be administered eight times after the priming drink is presented during the ASA.
Changes in CR responses to alcohol cues, in terms of psychophysiological responses,heart rate,mean arterial pressure and salivation changes during the CR session.
Time frame: At Day 3 and Day 13 during the two treatment phases
There are three experimental time periods of 3-minutes each during each CR session. Cotton swabs will be weighed at the end of each 3-minute block and the mean values for weight of salivation will be calculated. An average heart rate and an average mean arterial pressure will be calculated for each of these three time periods.
Changes in attention to the sight and smell of cues, as measured by Alcohol Attention Scale (AAS), during the CR.
Time frame: This endpoint will be measured twice in each CR session (Day 3 and Day 13) through the AAS.
Effects of GET 73 on the amount of alcohol consumed during the ASA. The maximum quantity of alcohol will be taken, to have a measure directly comparable to AUQ results
Time frame: At Day 3 and Day 13 during the two treatment phases
Changes in peak plasma concentration (Cmax) of alcohol after administration of GET 73 or placebo
Time frame: blood samples are drawn on Day 2 and Day 12 at baseline and then, following the start of alcohol consumption, for the next 8 hours or until the blood alcohol level is zero on 2 successive determinations
Cmax will be calculated at the peak level as mean value of overall subjects evaluated
Changes in time to peak plasma level (Tmax) of alcohol after administration of GET 73 or placebo
Time frame: blood samples are drawn on Day 2 and Day 12 at baseline and then, following the start of alcohol consumption, for the next 8 hours or until the blood alcohol level is zero on 2 successive determinations
Tmax will be evaluated as the time after administration corresponding to the time of peak plasma level and as mean value of overall subjects evaluated
Changes in half-life of alcohol after administration of GET 73 or placebo
Time frame: blood samples are drawn on Day 2 and Day 12 at baseline and then, following the start of alcohol consumption, for the next 8 hours or until the blood alcohol level is zero on 2 successive determinations
Half-life will be calculated as mean value of overall subjects evaluated
Characteristics of adverse events (AEs) occured after placebo or GET 73 administration
Time frame: up to 20-27 days
All AEs occurring during the study will be recorded. Subjects are discharged from the hospital at Day 13, after the two inpatient treatment phases (Day 1-Day 3 and Day 11-Day 13). A follow-up visit, approximately from 7 to 14 days after the second CR/ASA experiment, will be performed. The AEs will be grouped by Medical Dictionary for Regulatory Affairs preferred terms according to system organ class (SOC). When an AE occurs more than once for a subject, the maximal severity and strongest relationship to the medication will be counted. Characteristics of AEs occurred after placebo or GET 73 administration will be compared using chi-square or Fischer's exact test.

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 10 Apr 2019.

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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.

Robert M. Swift, M.D., R.Ph. principal investigator

Roger Williams Medical Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GET 73 and inactive ingredients capsule in people with Alcohol Dependence, run by Laboratorio Farmaceutico Ct S.r.l. 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 8 inclusion and 16 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 10 Apr 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

changes in area under the plasma concentration of alcohol versus time curve (AUC), after administration of GET 73 or placebo (time frame: blood samples are drawn on day 2 and day 12 at baseline and then, following the start of alcohol consumption, for the next 8 hours or until the blood alcohol level is zero on 2 successive determinations). The study lists 13 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 NCT01842503.

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 10 Apr 2019.