Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcoholism Smoking | Drug: Naltrexone Tablet and Nicotine Patch Drug: Naltrexone Tablet and Placebo Patch Drug: Placebo Tablet and Nicotine Patch Drug: Placebo Tablet and Placebo Patch | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
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 |
Official Title: | Nalmefene in Nicotine and Alcohol Dependence |
Actual Study Start Date : | September 26, 1997 |
Actual Primary Completion Date : | September 15, 2005 |
Actual Study Completion Date : | September 15, 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: Naltrexone Tablet and Nicotine Patch |
Drug: Naltrexone Tablet and Nicotine Patch
Other Name: Revia and Nicotrol |
Active Comparator: Naltrexone Tablet and Placebo Patch |
Drug: Naltrexone Tablet and Placebo Patch
Other Name: Revia |
Active Comparator: Placebo Tablet and Nicotine Patch |
Drug: Placebo Tablet and Nicotine Patch
Other Name: Nicotrol |
Placebo Comparator: Placebo Tablet and Placebo Patch |
Drug: Placebo Tablet and Placebo Patch |

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000437
United States, Florida | |
Department of Psychiatry, University of Miami School of Medicine | |
Miami, Florida, United States, 33136 |
Principal Investigator: | Barbara Mason, PhD | University of Miam |
Responsible Party: | Barbara J. Mason, Principal Investigator, The Scripps Research Institute |
ClinicalTrials.gov Identifier: | NCT00000437 |
Other Study ID Numbers: |
NIAAAMAS11210 R01AA011210 ( U.S. NIH Grant/Contract ) |
First Posted: | November 3, 1999 Key Record Dates |
Last Update Posted: | April 20, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Naltrexone Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Alcohol Deterrents Narcotic Antagonists Sensory System Agents |