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Sponsor: University of Chicago
Conditions: HIV, Tobacco Use, Alcohol Use Disorder
Interventions: Cystine, Positively Smoke Free, Placebo, Standard of Care
Countries: Kenya
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.
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Nairobi, Kenya
- Nairobi, Kenya