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Can a Plant-Based pill help HIV patients quit smoking and drinking?

NCT ID NCT06790342

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Mathari National Teaching and Referral Hospital

    Nairobi, Kenya

  • Riruta Health Centre

    Nairobi, Kenya

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