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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01362699

Collaborator

The Scripps Research Institute (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Aug 1, 2011

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Urge to drink [1 week]

Secondary Outcome Measures

The number of patients reporting adverse events as a measure of safety and tolerability [Up to approximately 15 days]
Abnormal findings from eye exams performed as a measure of safety and tolerability [Up to approximately 8-15 days]
Vital signs measurements as a measure of safety and tolerability [Up to approximately 15 days]
Electrocardiograms as a measure of safety and tolerability [Up to approximately 15 days]
Clinical Laboratory tests as a measure of safety and tolerability [Up to approximately 8 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 62 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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