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

This study has been withdrawn prior to enrollment.
(Re-prioritization lead to study cancellation.)
Sponsor:
Collaborator:
The Scripps Research Institute
Information provided by:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01362699
First received: May 19, 2011
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Alcoholism
Drug: JNJ-31001074
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Urge to drink [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of patients reporting adverse events as a measure of safety and tolerability [ Time Frame: Up to approximately 15 days ] [ Designated as safety issue: No ]
  • Abnormal findings from eye exams performed as a measure of safety and tolerability [ Time Frame: Up to approximately 8-15 days ] [ Designated as safety issue: No ]
  • Vital signs measurements as a measure of safety and tolerability [ Time Frame: Up to approximately 15 days ] [ Designated as safety issue: No ]
  • Electrocardiograms as a measure of safety and tolerability [ Time Frame: Up to approximately 15 days ] [ Designated as safety issue: No ]
  • Clinical Laboratory tests as a measure of safety and tolerability [ Time Frame: Up to approximately 8 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362699

Locations
United States, California
La Jolla, California, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
The Scripps Research Institute
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Compound Development Team Leader, Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01362699     History of Changes
Other Study ID Numbers: CR018802, 31001074ALC2001
Study First Received: May 19, 2011
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Alcohol Dependence
JNJ-31001074
Bavisant

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014