Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
Nalmefene in Nicotine and Alcohol Dependence
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 1997
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
November 3, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2005
CompletedApril 20, 2017
April 1, 2017
8 years
November 2, 1999
April 18, 2017
Conditions
Study Arms (4)
Naltrexone Tablet and Nicotine Patch
EXPERIMENTALNaltrexone Tablet and Placebo Patch
ACTIVE COMPARATORPlacebo Tablet and Nicotine Patch
ACTIVE COMPARATORPlacebo Tablet and Placebo Patch
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Meets criteria for alcohol dependence and nicotine dependence.
- Expresses a desire to cut down or stop drinking and smoking.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, University of Miami School of Medicine
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Mason, PhD
University of Miam
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind tablet and patch active study medications, and matched tablet and patch placebos
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 2, 1999
First Posted
November 3, 1999
Study Start
September 26, 1997
Primary Completion
September 15, 2005
Study Completion
September 15, 2005
Last Updated
April 20, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share