Alcohol DependencePhase 3ProjectSMARTNCT01115894
Medication and Counseling for Controlled Drinking
A Phase 3 study testing Naltrexone and Brief Behavioral Compliance Enhancement Therapy in people with Alcohol Dependence and Alcohol Abuse, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial summary
Problem drinking gay and bisexual men who try to quit drinking are at risk for relapse to heavy or problematic drinking because their social lives and social outlets are often strongly associated with alcohol. These men are most receptive to interventions focused on moderation of drinking rather than abstinence. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Alcohol Dependence, Alcohol Abuse
- What is being tested?
- Naltrexone and Brief Behavioral Compliance Enhancement Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2010
- Phase
- Phase 3
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently sexually active with other men
- Report drinking at levels substantially in excess of established guidelines for non-hazardous drinking
- Willing to reduce drinking to non-hazardous levels
- English literate (8th grade level)
Who cannot join
- Current physical disease or condition making participant inappropriate for a medication trial, including total bilirubin elevation >110% AST or ALT elevations >300%
- History of serious psychiatric illness (psychotic disorder, bipolar disorder, or psychiatric illness requiring hospitalization)
- Recent (past three month) initiation of psychotropic medication or psychotherapy, or recent change in psychotropic medication treatment
- Current DSM-IV diagnosis of drug (other than nicotine) dependence, or lifetime diagnosis of opioid dependence
- DSM-IV alcohol dependence diagnosis judged clinically severe, history or present evidence of significant alcohol withdrawal symptoms, or recurrent use of alcohol to alleviate withdrawal
- Regular use of opioids in the past month
Show all 9Show fewer
- History of of hypersensitivity to NTX
- Considered by study physician not to be suitable for receipt of an investigational drug
- Likely to require treatment with opiate pain medication during the course of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Addiction Services and Psychotherapy Intervention Research
New York, New York, 10019
About this study
Official title: Naltrexone and CBT for Problem-Drinking MSM
Problem drinking gay and bisexual men who try to quit drinking are at risk for relapse to heavy or problematic drinking because their social lives and social outlets are often strongly associated with alcohol. These men are most receptive to interventions focused on moderation of drinking rather than abstinence. However moderation-oriented cognitive-behavior therapy (CBT) and naltrexone (NTX) are both well established treatments for problem drinkers who wish to moderate, rather than stop, drinking. Research suggests that combining these treatments may enhance their efficacy.
This study combines moderation-oriented CBT with NTX in the treatment of problem drinking gay and bisexual men, who do not wish to abstain from alcohol, to evaluate their efficacy alone and in combination. We also propose to utilize new data collection technology, Interactive Voice Response, to collect data on daily relations among drinking, sexual behavior and psychological variables thought to mediate treatment response. Our objectives are to evaluation the efficacy of 12 weeks of randomly assigned treatment, with 100 mg of NTX or placebo, combined with brief supportive therapy or modified, behavioral self-control therapy specifically tailored to gay/bisexual men; to evaluate conditional relationships between heavy drinking and likelihood of HIV risk behavior; and to evaluate daily associations among mood, craving, self-efficacy, motivation, and drinking. Assessments will include baseline, 3, 6, \& 9 month follow-up. A substudy of the treatment trial will be conducted to collect and bank samples from blood for research aimed at associating naturally occurring differences in DNA with patient response to NTX, and with potential mediational mechanisms of action of NTX. Information gathered on genes or gene products may be used in conjunction with data on clinical psychological factors obtained as part of the clinical trial to evaluate relationships among genetic variants, drug effects, and mechanisms of treatment response. Patients will be asked to give a blood sample at Week 0 of the clinical trial for the purpose of carrying out genetic research.
- Conditions
- Alcohol Dependence, Alcohol Abuse
- Being tested
- Naltrexone, Modified Behavioral Self-Control Psychotherapy, Brief Behavioral Compliance Enhancement Therapy, Placebo
- Keywords
- problem drinking, alcohol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
100 mg oral dosage daily for 12 weeks
Modified Behavioral Self-Control PsychotherapyBehavioural
Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.
Brief Behavioral Compliance Enhancement TherapyBehavioural
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| active medication + psychotherapy | Experimental | Not described Receives: Drug: Naltrexone; Behavioral: Modified Behavioral Self-Control Psychotherapy |
| placebo + psychotherapy | Experimental | Not described Receives: Behavioral: Modified Behavioral Self-Control Psychotherapy; Drug: Placebo |
| active medication+brief supportive counseling | Experimental | Not described Receives: Drug: Naltrexone; Behavioral: Brief Behavioral Compliance Enhancement Therapy |
| placebo + brief supportive counseling | Experimental | Not described Receives: Behavioral: Brief Behavioral Compliance Enhancement Therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of alcohol use
Measured: 9 months
Frequency of binge drinking
Measured: 9 months
Secondary outcomes (1)
Frequency of HIV risk behavior
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startFeb 2007
- Primary completionDec 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Morgenstern, Ph.D., Research Foundation for Mental Hygiene, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115894
- Sponsor's protocol ID
- AA015553-01A1S1
- Acronym
- ProjectSMART
- Status last verified
- Dec 2012
- First submitted
- 30 Apr 2010
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone and CBT for Problem-Drinking MSM
- ClinicalTrials.gov ID
- NCT01115894
- Acronym / sponsor ID
- ProjectSMART / AA015553-01A1S1
- Conditions
- Alcohol Dependence, Alcohol Abuse
- Keywords
- problem drinking, alcohol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2010 (actual)
- First posted
- 4 May 2010 (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.
Problem drinking gay and bisexual men who try to quit drinking are at risk for relapse to heavy or problematic drinking because their social lives and social outlets are often strongly associated with alcohol. These men are most receptive to interventions focused on moderation of drinking rather than abstinence. However moderation-oriented cognitive-behavior therapy (CBT) and naltrexone (NTX) are both well established treatments for problem drinkers who wish to moderate, rather than stop, drinking. Research suggests that combining these treatments may enhance their efficacy.
This study combines moderation-oriented CBT with NTX in the treatment of problem drinking gay and bisexual men, who do not wish to abstain from alcohol, to evaluate their efficacy alone and in combination. We also propose to utilize new data collection technology, Interactive Voice Response, to collect data on daily relations among drinking, sexual behavior and psychological variables thought to mediate treatment response. Our objectives are to evaluation the efficacy of 12 weeks of randomly assigned treatment, with 100 mg of NTX or placebo, combined with brief supportive therapy or modified, behavioral self-control therapy specifically tailored to gay/bisexual men; to evaluate conditional relationships between heavy drinking and likelihood of HIV risk behavior; and to evaluate daily associations among mood, craving, self-efficacy, motivation, and drinking. Assessments will include baseline, 3, 6, \& 9 month follow-up. A substudy of the treatment trial will be conducted to collect and bank samples from blood for research aimed at associating naturally occurring differences in DNA with patient response to NTX, and with potential mediational mechanisms of action of NTX. Information gathered on genes or gene products may be used in conjunction with data on clinical psychological factors obtained as part of the clinical trial to evaluate relationships among genetic variants, drug effects, and mechanisms of treatment response. Patients will be asked to give a blood sample at Week 0 of the clinical trial for the purpose of carrying out genetic research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active medication + psychotherapy | Experimental | Drug: Naltrexone, Behavioral: Modified Behavioral Self-Control Psychotherapy |
| placebo + psychotherapy | Experimental | Behavioral: Modified Behavioral Self-Control Psychotherapy, Drug: Placebo |
| active medication+brief supportive counseling | Experimental | Drug: Naltrexone, Behavioral: Brief Behavioral Compliance Enhancement Therapy |
| placebo + brief supportive counseling | Experimental | Behavioral: Brief Behavioral Compliance Enhancement Therapy, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently sexually active with other men
- Report drinking at levels substantially in excess of established guidelines for non-hazardous drinking
- Willing to reduce drinking to non-hazardous levels
- English literate (8th grade level)
Key exclusion criteria (9 listed)
- Current physical disease or condition making participant inappropriate for a medication trial, including total bilirubin elevation >110% AST or ALT elevations >300%
- History of serious psychiatric illness (psychotic disorder, bipolar disorder, or psychiatric illness requiring hospitalization)
- Recent (past three month) initiation of psychotropic medication or psychotherapy, or recent change in psychotropic medication treatment
- Current DSM-IV diagnosis of drug (other than nicotine) dependence, or lifetime diagnosis of opioid dependence
- DSM-IV alcohol dependence diagnosis judged clinically severe, history or present evidence of significant alcohol withdrawal symptoms, or recurrent use of alcohol to alleviate withdrawal
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 |
|---|---|---|
| Naltrexone100 mg oral dosage daily for 12 weeks | Drug | active medication + psychotherapy, active medication+brief supportive counseling |
| Modified Behavioral Self-Control PsychotherapyModeration- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions. | Behavioural | active medication + psychotherapy, placebo + psychotherapy |
| Brief Behavioral Compliance Enhancement TherapyBrief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption. | Behavioural | active medication+brief supportive counseling, placebo + brief supportive counseling |
| PlaceboPlacebo | Drug | placebo + brief supportive counseling, placebo + psychotherapy |
Primary outcome
Quantity of alcohol use
Time frame: 9 months
Frequency of binge drinking
Time frame: 9 months
1 secondary outcome
Frequency of HIV risk behavior
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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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 3 study testing Naltrexone and Brief Behavioral Compliance Enhancement Therapy in people with Alcohol Dependence and Alcohol Abuse, run by Research Foundation for Mental Hygiene, Inc. 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Dec 2012. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Quantity of alcohol use (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2012.