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

NCT02797587 | Completed Phase 2 DMC

• 2 other identifiers: H-35288U01AA020780
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alcohol Use; Tobacco Use; Smoking; Inflammation; Coronary Heart Disease; Russia; Varenicline; Cytisine; Nicotine Replacement Therapy; Partial Agonist Therapy; HIV; Reynolds risk score; VACS index

Outcome Measures

Primary Outcomes (1)

• Percent heavy drinking days in past 30 days

  Self-reported past 30-day alcohol consumption obtained via the Timeline Followback (TLFB) method, heavy drinking defined by NIAAA definition

  Participants will be followed for up to 12 months (primary endpoint at 3 month)

Secondary Outcomes (7)

• Alcohol craving

  Participants will be followed for up to 12 months (primary endpoint at 3 month)

• Carbon monoxide-validated smoking cessation

  Participants will be followed for up to 12 months (primary endpoint at 3 month)

• Coronary heart disease risk

  Participants will be followed for up to 12 months (primary endpoint at 3 month)

• Mortality risk

  Participants will be followed for up to 12 months (primary endpoint at 3 month)

• Cigarettes per day in past 7 days

  Participants will be followed for up to 12 months (primary endpoint at 3 month)

Study Arms (4)

Varenicline + Nicotine Replacement Therapy placebo

ACTIVE COMPARATOR

Study participants will receive active varenicline and be instructed to take the medication for 12 weeks; participants will also receive a placebo Nicotine Replacement Therapy mouth spray for 8 weeks.

Drug: Varenicline; Drug: Nicotine Replacement Therapy Placebo

Varenicline placebo + Nicotine Replacement Therapy

PLACEBO COMPARATOR

Study participants will receive placebo varenicline and be instructed to take the placebo medication for 12 weeks; participants will also receive an active Nicotine Replacement Therapy mouth spray for 8 weeks.

Drug: Nicotine Replacement Therapy; Drug: Varenicline Placebo

Cytisine + Nicotine Replacement Therapy placebo

ACTIVE COMPARATOR

Study participants will receive active cytisine and be instructed to take the medication for 25 days; participants will also receive a placebo Nicotine Replacement Therapy mouth spray for 8 weeks.

Drug: Cytisine; Drug: Nicotine Replacement Therapy Placebo

Cytisine placebo + Nicotine Replacement Therapy

PLACEBO COMPARATOR

Study participants will receive placebo cytisine and be instructed to take the medication for 25 days; participants will also receive an active Nicotine Replacement Therapy mouth spray for 8 weeks.

Drug: Nicotine Replacement Therapy; Drug: Cytisine Placebo

Interventions

Varenicline DRUG

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

Varenicline + Nicotine Replacement Therapy placebo

Cytisine DRUG

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

Cytisine + Nicotine Replacement Therapy placebo

Nicotine Replacement Therapy DRUG

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

Cytisine placebo + Nicotine Replacement Therapy; Varenicline placebo + Nicotine Replacement Therapy

Varenicline Placebo DRUG

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

Varenicline placebo + Nicotine Replacement Therapy

Cytisine Placebo DRUG

Multi-daily dosing for 25 days.

Cytisine placebo + Nicotine Replacement Therapy

Nicotine Replacement Therapy Placebo DRUG

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

Cytisine + Nicotine Replacement Therapy placebo; Varenicline + Nicotine Replacement Therapy placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

First St. Petersburg Pavlov State Medical University

Saint Petersburg, 197022, Russia

Location

Related Publications (1)

• Tindle HA, Freiberg MS, Cheng DM, Gnatienko N, Blokhina E, Yaroslavtseva T, Bendiks S, Patts G, Hahn J, So-Armah K, Stein MD, Bryant K, Lioznov D, Krupitsky E, Samet JH. Effectiveness of Varenicline and Cytisine for Alcohol Use Reduction Among People With HIV and Substance Use: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225129. doi: 10.1001/jamanetworkopen.2022.25129.

  PMID: 35930287 DERIVED

Related Links

• URBAN ARCH, a member of NIAAA CHAART (Consortiums for HIV/AIDS \& Alcohol Research Translation) initiative, conducts and disseminates interdisciplinary research on how alcohol impacts people with HIV and develops interventions to reduce related outcomes.

MeSH Terms

Conditions

HIV Infections; Alcohol Drinking; Smoking; Tobacco Use; Inflammation; Coronary Disease

Interventions

Varenicline; cytisine; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Drug Therapy; Therapeutics

Study Officials

• Jeffrey H Samet, MA, MA, MPH

  Boston University/Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of General and Internal Medicine

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 13, 2016
• Study Start: July 19, 2017
• Primary Completion: April 30, 2020
• Study Completion: December 15, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)