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Varenicline + Prazosin for Heavy Drinking Smokers

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ClinicalTrials.gov Identifier: NCT02193256
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

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.


Condition or disease Intervention/treatment Phase
Cigarette Smoking Alcohol Use Disorders Drug: Varenicline Drug: Prazosin Drug: Placebo Early Phase 1

Detailed Description:

The study comprises an 8-week double-blind, within-subjects, crossover design of varenicline (up to 2mg per day) plus either prazosin (up to 8mg per day) (V+P) or placebo (V) with 20 heavy drinking smokers. Each medication phase is 3 weeks with a 2-week medication washout in between. Participants are asked to make a practice quit attempt for 3 days the last week of each medication phase.

This is an exploratory study to look at two primary aims:

  1. Evaluate the effect of prazosin on sleep disturbance caused by varenicline in heavy drinking smokers prior to quitting smoking.

    Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than V alone.

  2. Evaluate the effect of prazosin on sleep disturbance caused by varenicline during smoking cessation in heavy drinking smokers.

Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than V alone We will also investigate the combined effects of prazosin and varenicline on smoking behavior (i.e., smoking urge) and alcohol consumption (i.e., drinks per drinking day) as exploratory aims.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Trial of Varenicline and Prazosin to Treat Heavy Drinking Smokers
Study Start Date : July 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Varenicline plus Prazosin
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
Titrated over 1 week to a maximum dose of 2mg/day
Other Name: Chantix

Drug: Prazosin
Titrated over 3 weeks to a maximum dose of 8mg/day
Other Name: Minipress

Placebo Comparator: Varenicline plus Placebo
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
Titrated over 1 week to a maximum dose of 2mg/day
Other Name: Chantix

Drug: Placebo



Primary Outcome Measures :
  1. Effect of prazosin on sleep disturbance caused by varenicline prior to quitting smoking [ Time Frame: Two weeks ]
    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.

  2. Effect of prazosin on sleep disturbance caused by varenicline during smoking cessation [ Time Frame: One week ]
    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.


Other Outcome Measures:
  1. Number of cigarettes smoked [ Time Frame: Three weeks ]
    The investigators will compare the combined effects of prazosin and varenicline on the number of cigarettes smoked with varenicline alone.

  2. Number of drinks per drinking day [ Time Frame: Three weeks ]
    The investigators will compare the combined effects of prazosin and varenicline on alcohol consumption (i.e., number of drinks per drinking day) with varenicline alone as an exploratory aim.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. unable to complete the informed consent;
  2. do not meet criteria for heavy drinking;
  3. do not meet criteria for current smokers;
  4. unable to read/understand English;
  5. 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;
  6. meet criteria for alcohol dependence in past 12 months that is clinically severe;
  7. meet criteria for drug dependence in the last 12 months aside from marijuana, nicotine and alcohol;
  8. are seeking to quit smoking immediately;
  9. report current psychosis or suicidality;
  10. 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);
  11. exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:

    1. any unexplained elevations in liver enzymes (i.e. transaminases, bilirubin);
    2. clinically significant, unstable cardiovascular disease/uncontrolled hypertension;
    3. hepatic or renal impairment;
    4. severe obstructive pulmonary disease;
    5. diabetes mellitus requiring insulin or certain oral medications (i.e. sulfonylureas) and an A1C hemoglobin test score of >7 for participants not prescribed these medications;
    6. baseline systolic blood pressure higher than 150 mm Hg of diastolic blood pressure higher than 95 mm Hg; (g) are scheduled for cataract surgery; (h) have a diagnosis of narcolepsy;
  12. have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
  13. have a history of clinically significant allergic reactions;
  14. have used any psychotropic drug in the past month, except individuals who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months;
  15. intend to donate blood or blood products during the treatment phase of the study;
  16. have a Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 28 or weight less than 45 kg.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193256


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Lisa M Fucito, PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02193256     History of Changes
Other Study ID Numbers: K05AA014715 ( U.S. NIH Grant/Contract )
K05AA014715 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by Yale University:
varenicline
prazosin
cigarette smoking
alcohol drinking
sleep
dreams

Additional relevant MeSH terms:
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Varenicline
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Prazosin
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents