- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01362699
Effect of JNJ 31001074 on Urge to Drink in Alcohol-Dependent Adults
April 27, 2012 updated by: Janssen Research & Development, LLC
A Single Center, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Efficacy of JNJ 31001074 on Cue Induced Craving for Alcohol in Adult Subjects With Alcohol DependenceH3 Alcoholism
The purpose of this study is to assess whether JNJ-31001074 taken for 7 days reduces the urge to drink alcohol in alcohol-dependent study participants who are not seeking treatment.
Study Overview
Detailed Description
This study will evaluate whether JNJ 31001074 reduces the urge to drink alcohol in non treatment seeking, adult study participants with current alcohol dependence.
Individuals who meet criteria for study participation will be randomly assigned to one of two treatment groups (tablets containing JNJ 31001074 or placebo tablets with no active ingredients) in a 1:1 ratio.
Treatment group assignment will not be known by study participants or study staff.
Baseline assessments will be recorded and participants will return to the clinic for testing on the last day of taking their assigned study medication for 7 days at home.
Alcohol use is not allowed for 3 days prior to this end-of-dosing testing.
During this test, their urge to drink alcohol and their mood will be measured while they view various computer images and then are presented with (but do not drink) either a favorite alcoholic beverage or water.
Other measures will be collected during the study to evaluate the safety and tolerability of the study medication, including potential effects on sleep, as well as measures of thinking and cigarette smoking.
Participants will return for a follow-up visit approximately 1 week after finishing the study medication and completing the clinic assessment above.
Study participants will take one 3-mg tablet of JNJ-31001074 or matching placebo in the morning, preferably with food, for 7 days.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female
- Currently alcohol dependent but not seeking treatment
- Meets study criteria for amount of alcohol consumed
- Otherwise healthy
- Urge to drink increased by the presence of alcohol
- Able to complete and understand questionnaires and study procedures in English
- Willing and able to comply with the study requirements, including a 3-day period of alcohol abstinence and use of highly effective contraceptive methods
- Signed informed consent.
Exclusion Criteria:
- Pregnant or breast-feeding
- Significant medical or psychiatric conditions other than alcohol dependence
- History of, or at risk of, medically significant alcohol withdrawal syndrome
- Dependent on substances other than alcohol , nicotine or caffeine
- Smokes more than 1 pack of cigarettes per day or consumes more than 500 mg caffeine per day
- Has glaucoma, cataracts, a history of eye inflammation, eye injury, or eye surgery other than to correct vision
- Treatment in the past 1 month prior to screening with disulfiram (Antabuse), acamprosate (Campral), naltrexone (ReVia or Vivitrol), or topiramate (Topamax)
- In need of or currently taking any psychoactive medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Form=tablet, route=oral administration.
One tablet once daily for 7 days.
|
Experimental: JNJ-31001074
|
Type=exact number, unit=mg, number=3, form=tablet, route=oral use.
One tablet once daily for 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urge to drink
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of patients reporting adverse events as a measure of safety and tolerability
Time Frame: Up to approximately 15 days
|
Up to approximately 15 days
|
Abnormal findings from eye exams performed as a measure of safety and tolerability
Time Frame: Up to approximately 8-15 days
|
Up to approximately 8-15 days
|
Vital signs measurements as a measure of safety and tolerability
Time Frame: Up to approximately 15 days
|
Up to approximately 15 days
|
Electrocardiograms as a measure of safety and tolerability
Time Frame: Up to approximately 15 days
|
Up to approximately 15 days
|
Clinical Laboratory tests as a measure of safety and tolerability
Time Frame: Up to approximately 8 days
|
Up to approximately 8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Study Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
May 19, 2011
First Submitted That Met QC Criteria
May 26, 2011
First Posted (Estimate)
May 30, 2011
Study Record Updates
Last Update Posted (Estimate)
April 30, 2012
Last Update Submitted That Met QC Criteria
April 27, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR018802
- 31001074ALC2001 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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