MedTrace Logo

Varenicline + Prazosin for Heavy Drinking Smokers

NCT02193256 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-03-12

No results posted yet for this study

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

Interventions

DRUG

Varenicline

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

DRUG

Prazosin

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

DRUG

Placebo

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Lisa M Fucito, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-01-31
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02193256 on ClinicalTrials.gov