Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444418
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2007-03-06
Brief Title:
Medication and Counseling for Controlled Drinking Project SMART
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Study Overview
Official Title:
Naltrexone and CBT for Problem-drinking MSM
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to study the effectiveness of medication and specialized psychotherapy in helping gay and bisexual men who do not want to quit drinking learn how to reduce their drinking to healthier levels More information on the study is available at wwwprojectsmartnycorg
Detailed Description:
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 evaluate 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 gaybisexual 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 and 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
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 evaluate 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 gaybisexual 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 and 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH Grant AA015553-01A1S1 | None | None | None |