Please select the eligibility criteria that correspond to the clinical trial below.
Title: Development of a Methamphetamine Early Intervention
Brief Summary: Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.


Options:
A: Inclusion Criteria:

* Applicants in methadone treatment may be eligible to participate in Phase 1 of the study.
* Applicants will be blind to the full details of the eligibility criteria.
* Unemployed
* Provided a urine sample at intake with a detectable concentration of cocaine metabolite or provided a cocaine positive sample during regular urinalysis testing at a methadone maintenance program
* Met DSM-IV criteria for cocaine dependence
* Were receiving welfare benefits in Baltimore, MD
* Received a score of less than or equal to 80% correct on a reading assessment

Exclusion Criteria

* Being at imminent risk for suicide
* Reported hallucinations
* Being incarcerated or otherwise under constant monitoring
* Earned less than or equal to $200 in unreported taxable income from legal activity in the previous month
* Having physical limitations that prevented typing
B: Inclusion Criteria:

* Female Veteran
* 18-65 years of age
* Meet DSM-IV criteria for current SUD with "current" defined as meeting SUD criteria per the DSM-IV and having used a substance within the 90 days prior to intake (to be able to accurately evaluate changes in their substance use from baseline)
* Plan to stay in the Boston area for the next 6 months
* Have a mailing address and live close enough to come to the hospital once weekly for treatment and/or assessment
* Able to complete the Statement of Informed Consent
* Willing to participate in all assessments and breathalyzer/urine testing
* Willing to provide a release of information such that study staff can contact her other providers as needed regarding any concerns during her participation
* Able to obtain medical clearance
* Willing to allow us to contact family and/or friends if participant loses contact with us
* Literate
* Not pregnant or planning to become pregnant

Exclusion Criteria:

* Any acute medical condition that would interfere with the participant's ability to participate in treatment, or would be of such severity as to affect the individual's psychological functioning (e.g., cancer)
* Current bipolar I disorder, schizophrenia or other psychotic disorders or mental retardation or organic mental disorder (determined by screening interview)
* Any clinical sign that the client is not sufficiently stable to participate in the treatment, such as client's treatment provider indicating that participation in the treatment would be contraindicated
* Dangerousness that would present a threat to other staff or other clients (e.g., history of recent assault)
* Client is mandated to treatment
* Psychopharmacologic treatment that is planned to change or likely to change substantively over the 3-month active treatment phase (with "substantive" defined as any addition of a new medication or major shift in dosage)
C: Inclusion Criteria: McKinney Act criteria for homelessness; DSM IV diagnosis for Cocaine Dependence; self-reported use within the last 2 weeks; psychological distress indicated by score of 70 on 1 or more Brief Symptom Inventory scales; willingness to participate; no plans to move from Birmingham area for 18 months;

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Exclusion Criteria: cognitive impariment precluding informed consent; requiring immediate inpatient medical treatment
D: Inclusion Criteria:

* Anal sex with another man in the month prior to enrollment
* Use of methamphetamine on at least 2 days in the month prior to enrollment

Exclusion Criteria:

* Plans to move from the study catchment area within 6 months of enrollment
* A mutually monogamous relationships with a man of the same HIV status lasting 2 or more years

Answer: D