Varenicline + Prazosin for Heavy Drinking Smokers

NCT02193256 | Completed Early Phase 1 DMC

• 2 other identifiers: 1402013410K05AA014715
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of varenicline and prazosin on smoking, drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an FDA approved smoking cessation medication. Some smokers report sleep problems when taking varenicline. This study will test whether using prazosin, which is an FDA-approved blood pressure medication, in combination with varenicline reduces sleep problems that can be associated with using varenicline for smoking cessation. In addition, the study will examine the combined effects of these medications on smoking and drinking. Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice quit attempt. Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit attempt.

Conditions

Cigarette Smoking; Alcohol Use Disorders

Keywords

varenicline; prazosin; cigarette smoking; alcohol drinking; sleep; dreams

Outcome Measures

Primary Outcomes (2)

• Effect of prazosin on sleep disturbance caused by varenicline prior to quitting smoking

  Sleep disturbance will be measured using self-report questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Pittsburgh Sleep Diary, Dream Quality Questionnaire) and objective sleep-monitoring devices.

  Two weeks

• Effect of prazosin on sleep disturbance caused by varenicline during smoking cessation

  Sleep disturbance will be measured using self-report questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Pittsburgh Sleep Diary, Dream Quality Questionnaire) and objective sleep-monitoring devices.

  One week

Other Outcomes (2)

• Number of cigarettes smoked

  Three weeks

• Number of drinks per drinking day

  Three weeks

Study Arms (2)

Varenicline plus Prazosin

ACTIVE COMPARATOR

Varenicline: .5mg for 3 days then 1mg daily for 4 days (Week 1) then 2mg daily thereafter (Weeks 2-3). Prazosin: 1mg for 3 days, then 3mg for 4 days (Week 1), (2) 6mg for 3 days, then 8mg for 4 days (Week 2), and (3) 8mg (Week 3).

Drug: Varenicline; Drug: Prazosin

Varenicline plus Placebo

PLACEBO COMPARATOR

Varenicline: .5mg for 3 days then 1mg daily for 4 days (Week 1) then 2mg daily thereafter (Weeks 2-3). Placebo: placebo will be given instead of prazosin (Weeks 1-3)

Drug: Varenicline; Drug: Placebo

Interventions

Varenicline DRUG

Titrated over 1 week to a maximum dose of 2mg/day

Also known as: Chantix

Varenicline plus Placebo; Varenicline plus Prazosin

Prazosin DRUG

Titrated over 3 weeks to a maximum dose of 8mg/day

Also known as: Minipress

Varenicline plus Prazosin

Placebo DRUG

Varenicline plus Placebo

Eligibility Criteria

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

You may qualify if:

• at least 18 years of age;
• current smoker \[quantity of ≥ cigarettes per smoking day, frequency of ≥3 times per week, and urinary cotinine ≥2 on NicAlert dipstick;
• at least 4 occasions of heavy drinking in the past 30 days \[5 or 4 standard drinks per occasion for males and females, respectively\];
• no history of severe alcohol withdrawal syndrome;
• no new onset of psychiatric illness or psychotropic medications in last 90 days;
• no severe psychiatric illness \[schizophrenia, bipolar disorder\] or PTSD;
• no substance dependence other than nicotine, alcohol or marijuana;
• no medical contraindications for varenicline or prazosin;
• are willing to take medication and wear portable sleep monitoring devices;
• no risk for sleep apnea syndrome;
• able to read and write in English;
• not interested in quitting smoking immediately.

You may not qualify if:

• unable to complete the informed consent;
• do not meet criteria for heavy drinking;
• do not meet criteria for current smokers;
• unable to read/understand English;
• exhibit serious psychiatric illness (i.e. schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder), organic mood or mental disorders by history of psychological examination;
• meet criteria for alcohol dependence in past 12 months that is clinically severe;
• meet criteria for drug dependence in the last 12 months aside from marijuana, nicotine and alcohol;
• are seeking to quit smoking immediately;
• report current psychosis or suicidality;
• are a female of childbearing potential who is pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide);
• exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:
• any unexplained elevations in liver enzymes (i.e. transaminases, bilirubin);
• clinically significant, unstable cardiovascular disease/uncontrolled hypertension;
• hepatic or renal impairment;
• severe obstructive pulmonary disease;

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Alcoholism; Alcohol Drinking

Interventions

Varenicline; Prazosin

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Quinazolines

Study Officials

• Lisa M Fucito, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 17, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

US (1)