Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Brown University
Sponsor:
Information provided by (Responsible Party):
Christopher W. Kahler, Brown University
ClinicalTrials.gov Identifier:
NCT00938886
First received: July 13, 2009
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

To test whether naltrexone compared to placebo can reduce heavy drinking and improve smoking cessation outcomes in heavy drinkers seeking smoking cessation treatment.


Condition Intervention Phase
Hazardous Drinking
Cigarette Smoking
Drug: Naltrexone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Percent heavy drinking days [ Time Frame: Across the 6 months following smoking quit date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7-day point prevalence smoking abstinence [ Time Frame: 2, 8, 16, and 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone
50 mg daily naltrexone for 10 weeks
Drug: Naltrexone
Daily 50 mg naltrexone
Placebo Comparator: Placebo
Daily matched placebo pill
Drug: Placebo
Matched naltrexone placebo

Detailed Description:

A substantial portion of individuals seeking behavioral and pharmacological treatment for smoking cessation drink excessively with many reporting significant alcohol problems. Although these at-risk and problem drinkers are unlikely to choose abstinence from alcohol as a goal, many make substantial reductions in their drinking during and after their quit smoking attempt. Thus, the context of smoking cessation treatment offers a unique and valuable opportunity in which to apply brief interventions and pharmacotherapy to catalyze change in excessive drinking in a population with markedly elevated risk for negative health outcomes. In our recent randomized clinical trial, standard smoking cessation treatment that incorporated a brief alcohol intervention showed promise in reducing drinking as well as in improving smoking cessation outcomes among heavy drinkers. However, these effects were relatively modest, especially among the heaviest drinkers, indicating that further study is warranted of methods to address heavy drinking in smoking cessation including the use of relevant pharmacotherapy. Naltrexone, in particular, shows promise for this purpose.

The overall aim of this project is to test the efficacy of naltrexone as a pharmacotherapy for excessive drinking when delivered to at-risk or problem drinkers who are seeking smoking cessation treatment. The proposed clinical trial uses a between-subjects design in which 300 at-risk or problem drinkers seeking treatment for smoking cessation will be randomly assigned to receive either daily 50 mg naltrexone or placebo. Medication will be initiated 2 weeks prior to participants' smoking quit date and continue for 10 weeks. All participants also will receive transdermal nicotine patch and a counseling and medication management intervention that provides advice for smoking cessation, advice regarding the effects of heavy drinking on both smoking cessation and health, and monitoring and encouragement of compliance with medications. Drinking and smoking outcomes will be assessed at 2, 8, 16, and 26 weeks after participants' smoking quit date. The primary aim of the study is to test the hypothesis that naltrexone will result in greater reductions in heavy drinking relative to placebo. The secondary aim will test whether naltrexone results in superior smoking outcomes relative to placebo, and tertiary aims will examine interrelationships among motivation for changing drinking, compliance with naltrexone, and drinking and smoking outcomes.

This study represents the first of its kind to provide naltrexone in conjunction with an opportunistic brief alcohol intervention for at-risk and problem drinkers not seeking alcohol treatment. Testing the potential benefits of naltrexone among at-risk and problem drinkers who smoke is of very high significance for public health efforts to reduce the markedly elevated rates of morbidity and mortality observed in this large, yet relatively understudied group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1.) be at least 18 years of age, 2.) drink heavily at least once per month on average (≥4 drinks per occasion for women; ≥5 drinks for men), 3.) have smoked cigarettes regularly for at least one year, 4.) currently smoke at least 5 cigarettes a day, 5.) currently be using no other tobacco products or nicotine replacement therapy

Exclusion Criteria:

  • 1.) meet criteria for current substance dependence (excluding nicotine and alcohol); 2.) report opiate use in the past month, have a drug screen positive for opiates, or require opiate containing medications for pain management; 3.) meet criteria for a current major depressive or manic episode; 4.) are currently psychotic or suicidal; 5.) have an unstable or serious medical condition that would preclude use of the nicotine patch or naltrexone (e.g., unstable angina pectoris, severe arrhythmia, recent congestive heart failure); 6.) have aspartate aminotransferase or alanine aminotransferase levels of more than 3 times the reference range or elevated bilirubin levels; or 7.) are currently pregnant or lactating, intend to become pregnant, or are not using a reliable means of birth control.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938886

Contacts
Contact: Christopher Kahler, Ph.D. (401)863-6651 christopher_kahler@brown.edu

Locations
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02912
Contact: Christopher Kahler, Ph.D.    401-863-6651    Christopher_Kahler@brown.edu   
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Christopher W. Kahler, Ph.D. Brown University
  More Information

No publications provided

Responsible Party: Christopher W. Kahler, Professor of Behavioral and Social Sciences, Brown University
ClinicalTrials.gov Identifier: NCT00938886     History of Changes
Other Study ID Numbers: NIAAA-17181-1
Study First Received: July 13, 2009
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014