Overview
Effect of JNJ 31001074 on Urge to Drink in Alcohol-Dependent Adults
Status:
Withdrawn
Withdrawn
Trial end date:
2012-08-01
2012-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen Research & Development, LLCCollaborator:
The Scripps Research InstituteTreatments:
Ethanol
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