Can a Plant-Based pill help HIV patients quit smoking and drinking?
NCT ID NCT06790342
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study in Nairobi, Kenya, will test whether a drug called cytisine, combined with counseling, can help 300 people with HIV quit smoking and reduce heavy drinking. Participants will receive either cytisine or a placebo, plus either intensive counseling or standard advice. The goal is to see if this combination improves health outcomes in a resource-limited setting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cytisine (a plant-based drug to help quit smoking and reduce alcohol use)
- What this could lead to
- If successful, this could provide an effective, low-cost treatment option for people with HIV who smoke and drink heavily, potentially reducing their risk of serious health problems.
- What could go wrong
- This is a Phase 3 trial, but it's still early to know if cytisine works better than standard advice. The results may not apply to all populations, and side effects from cytisine are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mathari National Teaching and Referral Hospital
Nairobi, Kenya
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Riruta Health Centre
Nairobi, Kenya
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can Brain-Training games rewire the mind to fight alcohol addiction?
- Can a Stress-Hormone blocker take the edge off alcohol?
- Can a single talk session help cancer patients quit smoking?
- One extra therapy session may keep cancer patients off cigarettes