Crystal Methamphetamine Abuse, Crystal Methamphetamine Dependence
Conditions
Keywords
Crystal methamphetamine abuse, Crystal methamphetamine dependence, Sexual risk behavior, Men who have sex with men (MSM), Behavioral activation
Brief summary
The purpose of this study is to research a new behavioral treatment to reduce sexual risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal meth), and are at risk for HIV acquisition. This study proposes using a treatment based on our original pilot study that incorporates risk reduction and behavioral activation therapy. In order to help learn what types of treatment programs best help individuals who abuse crystal meth and engage in sexual risk-taking, we will compare our treatment to a control group. The treatment group will receive therapy incorporating behavioral risk reduction counseling with behavioral activation therapy to treat depression, helping individuals reengage in their life. The control group will receive the risk reduction counseling without the behavioral activation therapy. The current study hopes to explore the efficacy of this previous developed treatment in a two-arm pilot randomized controlled trial.
Detailed description
1. To estimate, in a two-arm pilot randomized controlled trial (RCT), the effect size of the proposed intervention on reductions in sexual risk taking and crystal meth use. The primary outcome is the number of unprotected anal sex acts and a secondary outcome is reduction in crystal meth use episodes over the follow up period. 2. To explore the degree to which improvements in sexual risk taking are associated with the conceptual mediators of the effects of the intervention: reductions in crystal meth use and increases in pleasurable (but safe) activities, BAT skills, use of risk reduction skills, and reductions in depressed mood.
Interventions
BEHAVIORALBehavioral Activation Therapy and Risk Reduction Counseling (BAT-RR)
This intervention is given to patients in the experimental condition only and is comprised of 10 sessions.
BEHAVIORALInformation, Motivation, Behavioral skills change approach to sexual risk reduction
The comparison condition will only receive the two IMB risk reduction sessions.
Sponsors
Fenway Community Health
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: 18 years or older * Self-reports as a man who has sex with men * HIV-uninfected and verifies serostatus at baseline (HIV antibody testing and positive tests will be confirmed by Western Blots; see Human Subjects for operational aspects) * Meets DSM-IV diagnostic criteria for crystal meth abuse/dependence * Self reported unprotected anal intercourse-receptive or insertive-with a non-monogamous male sexual partner, while concurrently using crystal meth (use of meth must be a few hours prior to, or during, sex) in the prior three months
Exclusion criteria
* Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview * Has lived in the greater Boston area for three months or less (as a means to enhance participant retention) * Discovery of active suicidal ideation at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sexual risk | Baseline and three months post-treatment; baseline and six months post-treatment | We will ask about number of unprotected and protected insertive and receptive anal, vaginal and oral sex acts with male and female sex partners separately for HIV seropositive, seronegative, and partners of unknown HIV status with questions from measures used in previous studies. We will use this to calculate the ratio of protected to unprotected acts, by serostatus partner, and by whether or not crystal meth was being used before or during sex. Baseline and three and six-month follow-up assessments will assess sexual risk taking in the previous 3-months to the assessment being completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in crystal methamphetamine use | Baseline and three months post-treatment; baseline and six months post-treatment | For the present study, we will administer relevant sections of the Drug and Alcohol sections of the NIDA-CTN Addictions Severity Index Lite (ASI-Lite). We will use this methodology to determine the number of days of drug use, specifically crystal meth, and the number of distinct crystal meth episodes between study assessment visits (i.e., separate crystal meth binges).In addition to the ASI-Lite, we will also collect participant self-report measures of substance use via the ACASI. We have adapted and will also use the CDC's National HIV Behavioral Surveillance Survey, MSM cycle. |
Countries
United States
Contacts
Primary ContactMatthew Mimiaga, ScD, MPH
Backup ContactJanna Gordon
Outcome results
None listed