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

Summary

This study is a randomized controlled trial (RCT) to compare the effects of varenicline, cytisine, and nicotine replacement therapy (NRT) to reduce: 1) alcohol use and craving, 2) smoking; and 3) inflammation and risk for coronary heart disease (CHD) and mortality among 400 HIV-infected Russians, with heavy alcohol consumption and tobacco use.

Conditions

• HIV Infection
• Alcohol Use
• Smoking

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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Boston Medical Center

  lead OTHER

Principal Investigators

• Jeffrey H Samet, MA, MA, MPH · Boston University/Boston Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-19

Primary Completion

2020-04-30

Completion

2020-12-15

Countries

• Russia

Study Locations