Effect of JNJ 31001074 on Urge to Drink in Alcohol-Dependent Adults
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.
|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|
- Urge to drink [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2012|
Type=exact number, unit=mg, number=3, form=tablet, route=oral use. One tablet once daily for 7 days.
|Placebo Comparator: Placebo||
Form=tablet, route=oral administration. One tablet once daily for 7 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362699
|United States, California|
|La Jolla, California, United States|
|Study Director:||Janssen Research & Development, LLC C. Clinical Trial||Janssen Research & Development, LLC|