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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Recruitment Status : Withdrawn (Re-prioritization lead to study cancellation.)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

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 30, 2011
Last Update Posted Date April 30, 2012
Study Start Date  ICMJE August 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
Urge to drink [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
Urge to drink [ Time Frame: 1 week ]
Craving for alcohol will be assessed using a 20 point visual analogue scale of craving after 1 week of medication.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • The number of patients reporting adverse events as a measure of safety and tolerability [ Time Frame: 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 ]
  • Vital signs measurements as a measure of safety and tolerability [ Time Frame: Up to approximately 15 days ]
  • Electrocardiograms as a measure of safety and tolerability [ Time Frame: Up to approximately 15 days ]
  • Clinical Laboratory tests as a measure of safety and tolerability [ Time Frame: Up to approximately 8 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
Cognitive Functioning [ Time Frame: 1 week ]
Neurocognitive functioning will be assessed pre- and post- medication intervention using a brief neuropsychological battery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effect of JNJ 31001074 on Urge to Drink in Alcohol-Dependent Adults
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • Drug: JNJ-31001074
    Type=exact number, unit=mg, number=3, form=tablet, route=oral use. One tablet once daily for 7 days.
  • Drug: Placebo
    Form=tablet, route=oral administration. One tablet once daily for 7 days.
Study Arms  ICMJE
  • Experimental: JNJ-31001074
    Intervention: Drug: JNJ-31001074
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 1, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2011)
Estimated Study Completion Date  ICMJE August 2012
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 62 Years   (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 NCT01362699
Other Study ID Numbers  ICMJE CR018802
31001074ALC2001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Compound Development Team Leader, Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE The Scripps Research Institute
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date April 2012

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