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

NCT ID: NCT00938886

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-12-31

Brief Summary

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

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.

Conditions

Hazardous Drinking; Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naltrexone

50 mg daily naltrexone for 10 weeks

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

Daily 50 mg naltrexone

Placebo

Daily matched placebo pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched naltrexone placebo

Interventions

Naltrexone

Daily 50 mg naltrexone

Intervention Type: DRUG

Placebo

Matched naltrexone placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Christopher W. Kahler

Professor of Behavioral and Social Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher W. Kahler, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

NIAAA-17181-1

Identifier Type: -

Identifier Source: org_study_id