Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya

Sponsor
University of Chicago
Study ID
NCT06790342
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cystine — DRUG
    Used for smoking cessation and alcohol reduction
  • Positively Smoke Free — BEHAVIORAL
    An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
  • Placebo — OTHER
    Matched to cystine
  • Standard of Care — OTHER
    Standardized brief advice to quit smoking (standard of care)

Study Details

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.

Key Dates

First listed
Jan 24, 2025
Start date
Jun 1, 2026
Status verified
Dec 2025
Primary completion
Aug 1, 2029
Completion
Feb 1, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Cystine (CYT) + Positively Smoke Free
    Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Cystine--used for smoking cessation and alcohol reduction
  • Experimental: Experimental: Cystine + Standard of Care
    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
  • Experimental: Experimental: Placebo + Positively Smoke Free
    Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Placebo--matched to bupropion
  • Placebo Comparator: Placebo Comparator: Placebo + Standard of Care.
    Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format

Primary Outcome Measure

7-day point prevalence abstinence (PPA) [ Time Frame: 36 months ]

Central Contacts

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