Completed

Nalmefene in Nicotine and Alcohol Dependence

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Naltrexone Tablet and Nicotine Patch

+ Naltrexone Tablet and Placebo Patch

+ Placebo Tablet and Nicotine Patch

Drug
Who is being recruted

Behavior+4

+ Mental Disorders

+ Substance-Related Disorders

From 18 to 65 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: September 1997
See protocol details

Summary

Principal SponsorThe Scripps Research Institute
Last updated: April 20, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 26, 1997

Actual date on which the first participant was enrolled.

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.

NCT00000437
Principal SponsorThe Scripps Research Institute
Last updated: April 20, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholismSmoking

Criteria

2 inclusion criteria required to participate
Expresses a desire to cut down or stop drinking and smoking
Meets criteria for alcohol dependence and nicotine dependence
12 exclusion criteria prevent from participating
Any history of opiate dependence or evidence of current opiate use
Chronic treatment with any narcotic-containing medications during the previous month
Current treatment with disulfiram (Antabuse) or nicotine replacement therapy
Currently meets criteria for dependence on substances other than alcohol and nicotine
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Group III

Active Comparator

Group IV

Placebo

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Psychiatry, University of Miami School of Medicine

Miami, United StatesOpen Department of Psychiatry, University of Miami School of Medicine in Google Maps
CompletedOne Study Center