A Phase 3 interventional study of Cystine and Positively Smoke Free in HIV, Tobacco Use and Alcohol Use Disorder, sponsored by University of Chicago. Not yet recruiting at 2 sites in Kenya. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of Chicago · Phase 3, Interventional, and Treatment
People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.
This study was reviewed and approved for data analysis by the University of Chicago.
The research portion of this study was also submitted to and is pending approval from:
Board Name: AMREF ETHICAL AND SCIENTIFIC REVIEW COMMITTEE (ESRC) Board Affiliation: The AMREF ESRC is affiliated with AMREF Health Africa and accredited by National Commission for Science, Technology and Innovation (NACOSTI) since 200 Phone: +254 20 699 4000 Email: esrc.kenya@amref.org
Address:
Langata Road PO Box 27691-00506 Nairobi, Kenya
420 studies on the registry are indexed under Tobacco Use; 82 are open to participants now.
This study's planned enrollment of 300 is above the median of 124 across 351 interventional studies indexed under Tobacco Use.
Browse Tobacco Use studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Cystine--used for smoking cessation and alcohol reduction
Drug: Cystine · Behavioral: Positively Smoke Free
Cystine--used for smoking cessation and alcohol reduction Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation
Drug: Cystine · Other: Standard of Care
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Placebo--matched to bupropion
Behavioral: Positively Smoke Free · Other: Placebo
Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format
Other: Placebo · Other: Standard of Care
Used for smoking cessation and alcohol reduction
An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
Matched to cystine
Standardized brief advice to quit smoking (standard of care)
7-day point prevalence abstinence (PPA)
Defined as self-reported no smoking in the past 7 days + Carbon Monoxide (CO)\<7 ppm
Time frame: 36 months
Dried blood spot phosphatidylethanol (PEth)
PEth level of less than 50ng/dl for cessation from heavy drinking linked (P30D)
Time frame: 36 months
Timeline Follow-Back (TLFB)
denial of self-reported heavy drinking days (denying any prior 7-day period with \>7 drinks or any single day with 4 drinks) for the past 30 days
Time frame: 36 months
Plan to share: No
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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