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

Alcoholism Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01362699
• Other study ID #: CR018802
• Secondary ID: 31001074ALC2001
• Status: Withdrawn
• Phase: Phase 2
• First received: May 19, 2011
• Last updated: April 27, 2012
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: April 2012
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 62 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• JNJ-31001074
Type=exact number, unit=mg, number=3, form=tablet, route=oral use. One tablet once daily for 7 days.
• Placebo
Form=tablet, route=oral administration. One tablet once daily for 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC	The Scripps Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urge to drink		1 week	No
Secondary	The number of patients reporting adverse events as a measure of safety and tolerability		Up to approximately 15 days	No
Secondary	Abnormal findings from eye exams performed as a measure of safety and tolerability		Up to approximately 8-15 days	No
Secondary	Vital signs measurements as a measure of safety and tolerability		Up to approximately 15 days	No
Secondary	Electrocardiograms as a measure of safety and tolerability		Up to approximately 15 days	No
Secondary	Clinical Laboratory tests as a measure of safety and tolerability		Up to approximately 8 days	No