Opioid-use DisorderPhase 2NCT03205423

Medication Development for Opioid and Alcohol Abuse

A Phase 2 study testing Gabapentin in people with Opioid-use Disorder and Alcohol Use Disorder, run by New York State Psychiatric Institute 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 present proposal will evaluate the ability of gabapentin maintenance to reduce the abuse liability of alcohol, oxycodone, and alcohol in combination with oxycodone in participants with both Opioid Use Disorder and Alcohol Use Disorder. Read more about this study

Who is it for?: Ages 21 to 59 years
Conditions the study is for: Opioid-use Disorder, Alcohol Use Disorder
What is being tested?: Gabapentin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2017to 30 Dec 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

DSM-5 criteria for moderate-severe opioid use disorder with physical dependence.
DSM-5 criteria for moderate-severe alcohol use disorder without physical dependence.
No current major mood, psychotic, or anxiety disorder.
Physically healthy.
Able to perform study procedures.
21-59 years of age.

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Normal body weight/Within 20% of body weight (for appropriate frame) according to 1983 Metropolitan Weight tables.
Current or history of illicit opioid use.
Current use of opioids in amounts and/or frequencies that meet or exceed those used in the proposed study (e.g., 3-4 tablets of a Rx opioid medication per day or 1-2 bags of heroin per day). Not seeking treatment for opioid use disorder (neutral attitude or not wanting treatment only).
Participants will consume alcohol at least 3 times per week (15 drinks per week for men and 8 drinks per week for women). In addition, they will drink alcohol and use opioids simultaneously.

Who cannot join

DSM-5 criteria for substance use disorder (moderate to severe) on drugs other than opioids, alcohol, nicotine or caffeine (must be less than 500 mg caffeine daily).
Participants requesting treatment.
Pregnancy or lactation.
Current or recent history of significant violent or suicidal behavior and/or suicidal/homicidal risk.
Cannot read or understand the self-report assessment forms unaided, or are so severely disabled that they cannot comply with the requirements of the study.
Elevated liver function tests (i.e., AST and ALT > 3 times the upper limit of normal) or impaired renal function (creatinine must be within normal limits).

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Physical disorders that might make participation hazardous such as AIDS, cancer, hypertension (blood pressure > 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease (please note that participants will be asked about previous visits to a cardiologist, chest pain, or strong palpitations; if these exist, they will be referred to a cardiologist and excluded unless cleared for participation by a cardiologist).
Current major Axis I psychopathology, other than OUD and AUD (e.g., mood disorder with functional impairment, schizophrenia), that might interfere with ability to participate in the study.
Sensitivity, allergy, or contraindication to opioids, alcohol, gabapentin or similar medications.
Taken an investigational drug within the past 30 days.
Current or history of chronic pain within the past 3 months.
Taking prescription psychotropic medications that would potentially interfere with study procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute in the Division on Substance Use Disorders
New York, New York, 10032

Other trials in United States

About this study

Official title: Medication Development for Opioid and Alcohol Abuse: Laboratory Study in Humans.

Read the detailed description

Currently, the abuse of prescription opioid medications is a pervasive problem in the U.S. In addition, co-abuse of opioids and alcohol represents a significant problem from the perspective of increased toxicity and decreased success in treatment. Surprisingly few studies have examined the effects of combined administration of opioids and alcohol in humans, and no clinical studies have examined the reinforcing effects of this combination. The current 8-9-week inpatient study will systematically evaluate gabapentin because it shows promise for treating both opioid and alcohol use disorders (OUD and AUD). The guiding principle is that a medication's effects on positive subjective responses and reinforcing effects are the best laboratory procedures to date in predicting its clinical efficacy. We will examine the ability of gabapentin (0 mg or 1800 mg) to alter opioid-, alcohol-,and combined opioid/alcohol-mediated responses. Participants will meet DSM-5 criteria for moderate-severe OUD and be physically dependent on opioids. In addition, participants will meet DSM-5 criteria for moderate-severe AUD, but they will not be physically dependent on alcohol. All of the participants will be maintained on oral morphine throughout the study and different doses of gabapentin will be evaluated.

Conditions: Opioid-use Disorder, Alcohol Use Disorder
Being tested: Gabapentin
Medical subject headings: Opioid-Related Disorders, Alcoholism

What participants receive

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

GabapentinDrug
Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.

Study groups in NCT03205423
Study group	Role	What they receive
Gabapentin 0 mg	Placebo comparator	once daily at 8am Receives: Drug: Gabapentin
Gabapentin 1800 mg	Active comparator	once daily at 8am Receives: Drug: Gabapentin

What is being measured

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

Peak Positive Subjective Responses to Placebo.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Measured: Assessed every 15 minutes following drug administration,for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Measured: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Measured: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Measured: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Measured: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Low Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Measured: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to High Alcohol Dose.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Measured: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (30mg)
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Measured: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Peak Positive Subjective Responses to Oxycodone (15mg)
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Measured: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.

Timeline

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

1 Aug 201730 Dec 2021

First posted2 Jul 2017
Study start1 Aug 2017
Primary completion30 Jun 2021
Study completion30 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid-use DisorderStudies 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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Participants will be randomized to receive one of two treatment conditions: gabapentin 0 mg or gabapentin 1800 mg/day first. Participants crossover to the 2nd gabapentin condition following a washout period.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03205423
Sponsor's protocol ID: 7476
Status last verified: Aug 2024
First submitted: 8 Mar 2017
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Castillo F, Harris HM, Lerman D, Bisaga A, Nunes EV, Zhang Z, Wall M, Comer SD. Clinical Implications of the Relationship Between Naltrexone Plasma Levels and the Subjective Effects of Heroin in Humans. J Addict Med. 2024 Mar-Apr 01;18(2):110-114. doi: 10.1097/ADM.0000000000001247. Epub 2023 Dec 20.
PubMed 38126709

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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Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
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All Opioid-use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medication Development for Opioid and Alcohol Abuse: Laboratory Study in Humans.
ClinicalTrials.gov ID: NCT03205423
Acronym / sponsor ID: 7476
Conditions: Opioid-use Disorder, Alcohol Use Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Study start: 1 Aug 2017 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Dec 2021 (actual)
First posted: 2 Jul 2017 (actual)
Results: Posted 6 Oct 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Participants will be randomized to receive one of two treatment conditions: gabapentin 0 mg or gabapentin 1800 mg/day first. Participants crossover to the 2nd gabapentin condition following a washout period.

Arm	Type	Receives
Gabapentin 0 mg	Placebo comparator	Drug: Gabapentinonce daily at 8am
Gabapentin 1800 mg	Active comparator	Drug: Gabapentinonce daily at 8am

Who may qualify

Ages: 21 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

DSM-5 criteria for moderate-severe opioid use disorder with physical dependence.
DSM-5 criteria for moderate-severe alcohol use disorder without physical dependence.
No current major mood, psychotic, or anxiety disorder.
Physically healthy.
Able to perform study procedures.

Key exclusion criteria (12 listed)

DSM-5 criteria for substance use disorder (moderate to severe) on drugs other than opioids, alcohol, nicotine or caffeine (must be less than 500 mg caffeine daily).
Participants requesting treatment.
Pregnancy or lactation.
Current or recent history of significant violent or suicidal behavior and/or suicidal/homicidal risk.
Cannot read or understand the self-report assessment forms unaided, or are so severely disabled that they cannot comply with the requirements of 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
GabapentinMaintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.	Drug	Gabapentin 0 mg, Gabapentin 1800 mg

Primary outcome

Peak Positive Subjective Responses to Placebo.
Time frame: Assessed every 15 minutes following drug administration,for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose.
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose.
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose.
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose.
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Peak Positive Subjective Responses to Low Alcohol Dose.
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Peak Positive Subjective Responses to High Alcohol Dose.
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Peak Positive Subjective Responses to Oxycodone (30mg)
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely
Peak Positive Subjective Responses to Oxycodone (15mg)
Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.
Self-reported "High" measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely

Results and safety

Results posted to the registry on 6 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gabapentin (Active First)	8	7
Gabapentin (Placebo First)	9	6

Primary outcome: Peak Positive Subjective Responses to Placebo.

Time frame: Assessed every 15 minutes following drug administration,for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.. Mean (Standard Deviation). Unit: units on a scale

Measure	Gabapentin 0 mg n = 13	Gabapentin 1800 mg n = 13
Value	3.3 (.8)	2.3 (.6)

Population analysed: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.

Primary outcome: Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose.

Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.. Mean (Standard Deviation). Unit: units on a scale

Measure	Gabapentin 0 mg n = 13	Gabapentin 1800 mg n = 13
Value	3.0 (.6)	9.1 (1.2)

Population analysed: Participants who completed both the active and placebo phases of the trial.

Primary outcome: Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose.

Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.. Mean (Standard Deviation). Unit: units on a scale

Measure	Gabapentin 0 mg n = 13	Gabapentin 1800 mg n = 13
Value	6.7 (1.1)	10.9 (1.3)

Population analysed: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.

Primary outcome: Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose.

Time frame: Assessed every 15 minutes following drug administration, for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.. Mean (Standard Deviation). Unit: units on a scale

Measure	Gabapentin 0 mg n = 13	Gabapentin 1800 mg n = 13
Value	6.3 (.9)	9.7 (1.3)

Population analysed: Participants who completed both the active and placebo gabapentin maintenance phases of the trial.

Adverse events

Time frame: Throughout the 4-week inpatient period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gabapentin (0 mg, i.e., Placebo)	0 of 17 (0%)	1 of 17 (5.9%)	0 of 17
Gabapentin (1800 mg i.e., Active)	0 of 17 (0%)	1 of 17 (5.9%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38126709Castillo F, Harris HM, Lerman D, Bisaga A, Nunes EV, Zhang Z, Wall M, Comer SD. Clinical Implications of the Relationship Between Naltrexone Plasma Levels and the Subjective Effects of Heroin in Humans. J Addict Med. 2024 Mar-Apr 01;18(2):110-114. doi: 10.1097/ADM.0000000000001247. Epub 2023 Dec 20.
Individual participant dataSharing planned: No

Related trials for Opioid-use Disorder

Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
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Active, not recruiting
Facilitating Opioid Care Connections
Opioid Court Model, Medication to Treat Opioid Use Disorder

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.

Sandra D. Comer, PhD. principal investigator

New York State Psychiatric Institute / Columbia University 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 2 study testing Gabapentin in people with Opioid-use Disorder and Alcohol Use Disorder, run by New York State Psychiatric Institute 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 10 inclusion and 12 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 19 Sep 2024. 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 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?

Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Peak Positive Subjective Responses to Placebo. (time frame: Assessed every 15 minutes following drug administration,for a total of 360 minutes. "Peak" drug effect is the highest rating throughout the entire testing session.). The study lists 9 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 NCT03205423, which also lists 1 linked publication.

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 19 Sep 2024.