NCT02797587View on ClinicalTrials.gov

Studying Partial-agonists for Ethanol and Tobacco Elimination in Russians With HIV (St PETER HIV)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

July 19, 2017

Primary Completion Date

April 30, 2020

Study Completion Date

December 15, 2020

Conditions
HIV InfectionAlcohol UseSmoking
Interventions
DRUG

Varenicline

1 week starter kit followed by 1mg twice daily for 12 weeks.

DRUG

Cytisine

Multi-daily dosing, range 3-9 mg daily for 25 days.

DRUG

Nicotine Replacement Therapy

Mouth spray dosing based on standard recommendations tapered over 8 weeks.

DRUG

Varenicline Placebo

1 week starter kit followed by 1 pill twice daily for 12 weeks.

DRUG

Cytisine Placebo

Multi-daily dosing for 25 days.

DRUG

Nicotine Replacement Therapy Placebo

Mouth spray dosing based on standard recommendations tapered over 8 weeks.

Trial Locations (1)

197022

First St. Petersburg Pavlov State Medical University, Saint Petersburg

Sponsors
All Listed Sponsors
collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

lead

Boston Medical Center

OTHER

NCT02797587 - Studying Partial-agonists for Ethanol and Tobacco Elimination in Russians With HIV (St PETER HIV) | Biotech Hunter | Biotech Hunter