Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318409
Status:
COMPLETED
Last Update Posted:
2014-10-17
First Post:
2006-04-24
Brief Title:
Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM
Sponsor:
San Francisco Department of Public Health
Organization:
San Francisco Department of Public Health
Study Overview
Official Title:
Pilot Study of Acceptability of Bupropion Treatment for Methamphetamine Dependence Among Men Who Have Sex With Men
Status:
COMPLETED
Status Verified Date:
2014-10
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:
Studies demonstrate that methamphetamine meth use is associated with high-risk sexual behavior among MSM putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV No studies have tested the feasibility and acceptability of conducting pharmacologic interventions to reduce meth use and meth-associated sexual risk behavior among MSM The purpose of this pilot study is to determine the feasibility enrolling and retaining meth-dependent MSM into a pharmacologic study of bupropion vs placebo and measuring the tolerability of and adherence to medication among these participants
Detailed Description:
The high rate of meth use among MSM is paralleled by evidence of rises in sexual risk behavior and HIV infection among this population The MSM meth epidemic and its link with HIV transmission underscores the need to pilot test new innovative modalities to reduce meth use and meth-associated sexual risk behavior Ultimately a pharmacologic treatment for meth use may not only serve to improve outcomes among those who are accessing current treatment services but might also benefit those who are not willing or able to utilize such services While studies show that MSM who enter substance use treatment decrease both their substance use and sexual risk behavior current behavioral meth treatment programs report low rates of success in treating meth dependence among MSM We believe the time has come to test the acceptability of pharmacologic interventions to reduce meth use among MSM and to assess the feasibility of conducting such trials among sexually active meth-dependent MSM whose meth-associated sexual behavior use places them at extraordinarily high risk for transmitting or acquiring HIV In this pilot study we will provide meth-dependent MSM with placebo or daily bupropion XL extended-release a well-tolerated dopamine agonist that has potential to reduce meth use The specific aims of this study are
1 To assess the feasibility of enrolling and retaining meth-dependent MSM into a randomized double-blind study of bupropion versus placebo with biologic urine meth testing and behavioral sexual risk measures
2 To explore the tolerability of bupropion and placebo among meth-dependent MSM as determined by the number of adverse clinical events in the bupropion and placebo arms
3 To describe the acceptability of bupropion and placebo among meth-dependent MSM by measuring via electronic pill caps medication adherence to bupropion and placebo
This randomized double-blind placebo-controlled two-arm pilot study will enroll 30 meth-dependent MSM assigned to receive 3 months of bupropion XL 300 mg daily or placebo We will include both HIV- and HIV-INFECTED MSM because meth use is common in both groups We will enroll meth-dependent MSM because they are the most likely population to benefit from this potential treatment Participants will be seen weekly for urine specimen collection and substance-use counseling Clinical exams medical history specimen collection and behavioral assessments will be performed at baseline and at the 1 2 and 3 month visits Interim visits will be scheduled whenever indicated by signs or symptoms Our decision to maintain participants on 3 months of bupropion is based on the smoking literature which demonstrated bupropions efficacy in treating nicotine addiction within similar time periods we anticipate that any future efficacy trial will maintain participants on bupropion for this duration
1 To assess the feasibility of enrolling and retaining meth-dependent MSM into a randomized double-blind study of bupropion versus placebo with biologic urine meth testing and behavioral sexual risk measures
2 To explore the tolerability of bupropion and placebo among meth-dependent MSM as determined by the number of adverse clinical events in the bupropion and placebo arms
3 To describe the acceptability of bupropion and placebo among meth-dependent MSM by measuring via electronic pill caps medication adherence to bupropion and placebo
This randomized double-blind placebo-controlled two-arm pilot study will enroll 30 meth-dependent MSM assigned to receive 3 months of bupropion XL 300 mg daily or placebo We will include both HIV- and HIV-INFECTED MSM because meth use is common in both groups We will enroll meth-dependent MSM because they are the most likely population to benefit from this potential treatment Participants will be seen weekly for urine specimen collection and substance-use counseling Clinical exams medical history specimen collection and behavioral assessments will be performed at baseline and at the 1 2 and 3 month visits Interim visits will be scheduled whenever indicated by signs or symptoms Our decision to maintain participants on 3 months of bupropion is based on the smoking literature which demonstrated bupropions efficacy in treating nicotine addiction within similar time periods we anticipate that any future efficacy trial will maintain participants on bupropion for this duration
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 |
|---|---|---|---|
| R21DA021090 | NIH | None | httpsreporternihgovquickSearchR21DA021090 |