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Effect of JNJ 31001074 on Urge to Drink in Alcohol-Dependent Adults

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. Identifier: NCT01362699
Recruitment Status : Withdrawn (Re-prioritization lead to study cancellation.)
First Posted : May 30, 2011
Last Update Posted : April 30, 2012
The Scripps Research Institute
Information provided by:
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: JNJ-31001074 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2011
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: JNJ-31001074 Drug: JNJ-31001074
Type=exact number, unit=mg, number=3, form=tablet, route=oral use. One tablet once daily for 7 days.

Placebo Comparator: Placebo Drug: Placebo
Form=tablet, route=oral administration. One tablet once daily for 7 days.

Primary Outcome Measures :
  1. Urge to drink [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. The number of patients reporting adverse events as a measure of safety and tolerability [ Time Frame: Up to approximately 15 days ]
  2. Abnormal findings from eye exams performed as a measure of safety and tolerability [ Time Frame: Up to approximately 8-15 days ]
  3. Vital signs measurements as a measure of safety and tolerability [ Time Frame: Up to approximately 15 days ]
  4. Electrocardiograms as a measure of safety and tolerability [ Time Frame: Up to approximately 15 days ]
  5. Clinical Laboratory tests as a measure of safety and tolerability [ Time Frame: Up to approximately 8 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01362699

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United States, California
La Jolla, California, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
The Scripps Research Institute
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Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Compound Development Team Leader, Janssen Research & Development, LLC Identifier: NCT01362699    
Other Study ID Numbers: CR018802
31001074ALC2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012
Keywords provided by Janssen Research & Development, LLC:
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Alcohol Dependence
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders