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Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Primary Purpose

Alcoholism, Smoking

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naltrexone Tablet and Nicotine Patch
Naltrexone Tablet and Placebo Patch
Placebo Tablet and Nicotine Patch
Placebo Tablet and Placebo Patch
Sponsored by
The Scripps Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets criteria for alcohol dependence and nicotine dependence. Expresses a desire to cut down or stop drinking and smoking. Exclusion Criteria: Currently meets criteria for dependence on substances other than alcohol and nicotine. Any history of opiate dependence or evidence of current opiate use. Significant medical disorders that will increase potential risk or interfere with study participation. Liver function tests more than 3 times normal or elevated bilirubin. Females who are pregnant, nursing, or not using a reliable method of birth control. Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy. Inability to understand and/or comply with the provisions of the protocol and consent form. Treatment with an investigational drug during the previous month. Chronic treatment with any narcotic-containing medications during the previous month. Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists. Current treatment with disulfiram (Antabuse) or nicotine replacement therapy. More than 6 weeks of abstinence.

Sites / Locations

  • Department of Psychiatry, University of Miami School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Naltrexone Tablet and Nicotine Patch

Naltrexone Tablet and Placebo Patch

Placebo Tablet and Nicotine Patch

Placebo Tablet and Placebo Patch

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
April 18, 2017
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000437
Brief Title
Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
Official Title
Nalmefene in Nicotine and Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 26, 1997 (Actual)
Primary Completion Date
September 15, 2005 (Actual)
Study Completion Date
September 15, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.
Detailed Description
Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind tablet and patch active study medications, and matched tablet and patch placebos
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone Tablet and Nicotine Patch
Arm Type
Experimental
Arm Title
Naltrexone Tablet and Placebo Patch
Arm Type
Active Comparator
Arm Title
Placebo Tablet and Nicotine Patch
Arm Type
Active Comparator
Arm Title
Placebo Tablet and Placebo Patch
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone Tablet and Nicotine Patch
Other Intervention Name(s)
Revia and Nicotrol
Intervention Type
Drug
Intervention Name(s)
Naltrexone Tablet and Placebo Patch
Other Intervention Name(s)
Revia
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet and Nicotine Patch
Other Intervention Name(s)
Nicotrol
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet and Placebo Patch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets criteria for alcohol dependence and nicotine dependence. Expresses a desire to cut down or stop drinking and smoking. Exclusion Criteria: Currently meets criteria for dependence on substances other than alcohol and nicotine. Any history of opiate dependence or evidence of current opiate use. Significant medical disorders that will increase potential risk or interfere with study participation. Liver function tests more than 3 times normal or elevated bilirubin. Females who are pregnant, nursing, or not using a reliable method of birth control. Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy. Inability to understand and/or comply with the provisions of the protocol and consent form. Treatment with an investigational drug during the previous month. Chronic treatment with any narcotic-containing medications during the previous month. Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists. Current treatment with disulfiram (Antabuse) or nicotine replacement therapy. More than 6 weeks of abstinence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Mason, PhD
Organizational Affiliation
University of Miam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

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