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

NCT00938886 | Completed Phase 2 Results DMC

• 1 other identifier: NIAAA-17181-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hazardous Drinking; Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Percent Heavy Drinking Days

  Defined for women as percent of days drinking 4 or more drinks in a day. For men, percent of days drinking 5 or more drinks in a day

  Across the 6 months following smoking quit date

Secondary Outcomes (1)

• 7-day Point Prevalence Smoking Abstinence

  26 weeks after target quit smoking date

Study Arms (2)

Naltrexone

EXPERIMENTAL

50 mg daily naltrexone for 10 weeks

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Daily matched placebo pill

Drug: Placebo

Interventions

Naltrexone DRUG

Daily 50 mg naltrexone

Naltrexone

Placebo DRUG

Matched naltrexone placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ) 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

You may not qualify if:

• ) 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.

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Christopher Kahler
• Organization: Brown University

christopher_kahler@brown.edu

401 863-6651

Study Officials

• Christopher W. Kahler, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Behavioral and Social Sciences

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-04

Locations

US (1)