Health Trials

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

ConditionsHIVTobacco UseAlcohol Use Disorder
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed chart diagnosis of HIV

At least 18 years or age

Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.

Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)

Disqualifiers

Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment

Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)

History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations

Pregnant, nursing, or becoming pregnant during the study

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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 intervention

    Matched to cystine

  • Standard of Care

    Other intervention

    Standardized brief advice to quit smoking (standard of care)

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Experimental: Cystine (CYT) + Positively Smoke FreeExperimental treatment 2 interventions
Group B: Experimental: Cystine + Standard of CareExperimental treatment 2 interventions
Group C: Experimental: Placebo + Positively Smoke FreeExperimental treatment 2 interventions
Group D: Placebo Comparator: Placebo + Standard of Care.Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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
2

Dried blood spot phosphatidylethanol (PEth)

PEth level of less than 50ng/dl for cessation from heavy drinking linked (P30D)

Time frame
36 months
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of Maryland

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: