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

• Status: Completed
• Trial end date: 2020-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Nicotine; Varenicline

Criteria

Inclusion Criteria:

• 18-70 years old

• HIV-infected

• ≥ 5 heavy drinking days in the past 30 days (NIAAA at-risk drinking levels)

• Smoking an average of at least 5 cigarettes per day

• Provision of contact information for 2 contacts to assist with follow-up

• Stable address within 100 kilometers

• Possession of a telephone (home or cell)

• Interest in cutting down/quitting alcohol or tobacco

• Able and willing to comply with all study protocols and procedures

Exclusion Criteria:

• Not fluent in Russian

• Cognitive impairment

• Pregnant or planning to become pregnant in next 3 months

• Breastfeeding

• Unstable psychiatric illness (i.e. ,answered yes to any of the following: past three month a) active hallucinations; b) mental health symptoms prompting a visit to the ED or hospital; mental health medication changes due to worsening symptoms; presence of suicidal ideations)

• History of pheochromocytoma

• Taking smoking cessation medications in past 30 days

• History of seizures

• History of Buerger's disease

• Acute coronary syndrome within 1 month of enrollment

• Systolic BP > 180 mm Hg or diastolic BP > 105 mm Hg

• Currently taking anti-tuberculosis medications

• Currently taking Galantamine or Physostigmine

• BAC level of 0.10% or higher

• Known allergy to varenicline (Chantix) or cytisine (Tabex)