Overview

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

Status:
Withdrawn
Trial end date:
2012-08-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Collaborator:
The Scripps Research Institute
Treatments:
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