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

The University of Chicago

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: HIV; Alcohol Use Disorder; Tobacco Use

Treatments: Behavioral: Positively Smoke Free; Other: Standard of Care; Drug: Cystine; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06790342

IRB24-1626

1R01CA288235-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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: [phone] Email: [e-mail]

Address:

Langata Road PO Box 27691-00506 Nairobi, Kenya

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed chart diagnosis of HIV
2. At least 18 years or age
3. 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.
4. Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)
5. Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse/heavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or >7 drinks/week over the past 30 days
6. Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)
7. Willingness to accept behavioral and/or pharmacologic tobacco and alcohol treatment
8. Willingness and ability to provide informed consent to participate.

Exclusion criteria

1. Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment
2. Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)
3. History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations
4. Pregnant, nursing, or becoming pregnant during the study
5. Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician
6. Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale
7. Unstable psychiatric illness
8. Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period
9. Expected survival of less than 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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300 participants in 4 patient groups, including a placebo group

Experimental: Cystine (CYT) + Positively Smoke Free

Experimental group

Description:

Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Cystine--used for smoking cessation and alcohol reduction

Treatment:

Drug: Cystine

Behavioral: Positively Smoke Free

Experimental: Cystine + Standard of Care

Experimental group

Description:

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

Treatment:

Other: Standard of Care

Drug: Cystine

Experimental: Placebo + Positively Smoke Free

Experimental group

Description:

Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Placebo--matched to bupropion

Treatment:

Other: Placebo

Behavioral: Positively Smoke Free

Placebo Comparator: Placebo + Standard of Care.

Placebo Comparator group

Description:

Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format

Treatment:

Other: Placebo

Other: Standard of Care