HIV Infections Clinical Trial
Official title:
Pilot Study of Acceptability of Bupropion Treatment for Methamphetamine Dependence Among Men Who Have Sex With Men.
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.
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 bupropion's efficacy in treating nicotine addiction within similar time
periods; we anticipate that any future efficacy trial will maintain participants on
bupropion for this duration.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |