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Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000437
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE November 3, 1999
Last Update Posted Date April 20, 2017
Actual Study Start Date  ICMJE September 26, 1997
Actual Primary Completion Date September 15, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
Official Title  ICMJE Nalmefene in Nicotine and Alcohol Dependence
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind tablet and patch active study medications, and matched tablet and patch placebos
Primary Purpose: Treatment
Condition  ICMJE
  • Alcoholism
  • Smoking
Intervention  ICMJE
  • Drug: Naltrexone Tablet and Nicotine Patch
    Other Name: Revia and Nicotrol
  • Drug: Naltrexone Tablet and Placebo Patch
    Other Name: Revia
  • Drug: Placebo Tablet and Nicotine Patch
    Other Name: Nicotrol
  • Drug: Placebo Tablet and Placebo Patch
Study Arms  ICMJE
  • Experimental: Naltrexone Tablet and Nicotine Patch
    Intervention: Drug: Naltrexone Tablet and Nicotine Patch
  • Active Comparator: Naltrexone Tablet and Placebo Patch
    Intervention: Drug: Naltrexone Tablet and Placebo Patch
  • Active Comparator: Placebo Tablet and Nicotine Patch
    Intervention: Drug: Placebo Tablet and Nicotine Patch
  • Placebo Comparator: Placebo Tablet and Placebo Patch
    Intervention: Drug: Placebo Tablet and Placebo Patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2017)
60
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
166
Actual Study Completion Date  ICMJE September 15, 2005
Actual Primary Completion Date September 15, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000437
Other Study ID Numbers  ICMJE NIAAAMAS11210
R01AA011210 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barbara J. Mason, The Scripps Research Institute
Study Sponsor  ICMJE The Scripps Research Institute
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Barbara Mason, PhD University of Miam
PRS Account The Scripps Research Institute
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP