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

NCT ID: NCT02797587

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2020-12-15

Brief Summary

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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.

Detailed Description

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HIV-infected heavy drinking smokers are at high risk for coronary heart disease (CHD) and death. The mechanisms driving increased CHD risk in HIV-infected people are unclear, but are linked to inflammation. HIV, heavy drinking, and smoking are all pro-inflammatory. HIV viral suppression with antiretroviral therapy does not eliminate the elevated CHD risk nor the increased inflammation (i.e., pre-HIV infection levels are not restored). Interventions that reduce alcohol use, smoking, or both in HIV-infected people could lower inflammation, CHD and death risk. Varenicline and cytisine are proven therapies for smoking cessation. When compared to placebo, varenicline has higher cessation rates than cytisine. Human trials suggest varenicline also has efficacy for reducing alcohol consumption and craving in heavy drinking smokers. In murine models, cytisine reduces alcohol consumption. The comparative efficacy of varenicline and cytisine to reduce alcohol consumption and by extension, inflammation, CHD, and mortality risk, in humans has not been tested, nor has their comparative effectiveness been tested for smoking. Neither drug has been tested for smoking cessation against nicotine replacement therapy (NRT) in HIV-infected heavy drinking smokers. Three compelling reasons to test varenicline and cytisine in HIV-infected heavy drinking smokers are: 1) both show promise in HIV-uninfected people; 2) the morbidity caused by heavy drinking and smoking in HIV-infected persons is significant; and 3) treating heavy drinking and smoking with one medication represents a significant advance in reducing polypharmacy and improving patient care. Thus, investigators propose a 4-arm placebo-controlled randomized controlled trial (RCT) among 400 HIV-infected heavy drinking smokers. Trial arms are varenicline+NRT placebo, cytisine+NRT placebo, NRT+varenicline placebo, NRT+cytisine placebo. All participants will receive counseling (alcohol \& tobacco) and medications (placebo \& active). Specific aims will compare effects of varenicline, cytisine, and NRT at 3 months on past month % heavy drinking days and alcohol craving, cigarettes per day and smoking abstinence (verified by carbon monoxide), inflammation (hsCRP, IL-6), CHD (Reynolds risk score), and mortality (VACS index) risk. Investigators hypothesize that (1) Varenicline has greater efficacy than NRT for reducing heavy drinking, smoking, inflammation, CHD and mortality risk; (2) Cytisine has greater efficacy than NRT; and (3) Varenicline has greater efficacy than cytisine for these outcomes. Investigators will conduct an RCT, Studying Partial-agonists for Ethanol and Tobacco Elimination in Russians with HIV (St PETER HIV), in a country with an HIV epidemic and high per-capita alcohol consumption and smoking. Investigators will recruit from the ongoing Russia ARCH cohort in St. Petersburg (part of our NIAAA funded HIV/AIDS Alcohol Consortium - URBAN ARCH). If investigator hypotheses are correct, St PETER HIV could make nicotinic partial-agonists standard care for HIV+ heavy drinking smokers, and lead to reduced inflammation, CHD and mortality risk through this "one drug, two diseases" approach. This trial addresses the paucity of RCT data to guide treatment of these CHD risk factors in HIV-infected people.

The Russia ARCH Cohort and the St PETER HIV study will draw from an established cohort of HIV-infected smokers and heavy drinkers to compare the effects of two partial nicotinic receptors, varenicline and cytisine, on alcohol consumption, alcohol craving, smoking, inflammation, CHD risk and mortality risk. St PETER HIV further addresses the paucity of randomized controlled trial data to guide treatment of heavy alcohol consumption and smoking in HIV-infected people.

Conditions

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HIV Infection Alcohol Use Smoking

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Varenicline + Nicotine Replacement Therapy placebo

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.

Group Type ACTIVE_COMPARATOR

Varenicline

Intervention Type DRUG

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

Nicotine Replacement Therapy Placebo

Intervention Type DRUG

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

Varenicline placebo + Nicotine Replacement Therapy

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.

Group Type PLACEBO_COMPARATOR

Nicotine Replacement Therapy

Intervention Type DRUG

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

Varenicline Placebo

Intervention Type DRUG

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

Cytisine + Nicotine Replacement Therapy placebo

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.

Group Type ACTIVE_COMPARATOR

Cytisine

Intervention Type DRUG

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

Nicotine Replacement Therapy Placebo

Intervention Type DRUG

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

Cytisine placebo + Nicotine Replacement Therapy

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.

Group Type PLACEBO_COMPARATOR

Nicotine Replacement Therapy

Intervention Type DRUG

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

Cytisine Placebo

Intervention Type DRUG

Multi-daily dosing for 25 days.

Interventions

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Varenicline

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

Intervention Type DRUG

Cytisine

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

Intervention Type DRUG

Nicotine Replacement Therapy

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

Intervention Type DRUG

Varenicline Placebo

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

Intervention Type DRUG

Cytisine Placebo

Multi-daily dosing for 25 days.

Intervention Type DRUG

Nicotine Replacement Therapy Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Samet

Chief, Section of General and Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey H Samet, MA, MA, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University/Boston Medical Center

Locations

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First St. Petersburg Pavlov State Medical University

Saint Petersburg, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type DERIVED
PMID: 35930287 (View on PubMed)

Related Links

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http://www.urbanarch.org

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.

Other Identifiers

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U01AA020780

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-35288

Identifier Type: -

Identifier Source: org_study_id