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

NCT01362699 | Withdrawn Phase 2 DMC

• 2 other identifiers: CR01880231001074ALC2001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Keywords

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Mental Disorders; Alcohol Dependence; JNJ-31001074; Bavisant

Outcome Measures

Primary Outcomes (1)

• Urge to drink

  1 week

Secondary Outcomes (5)

• 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

Study Arms (2)

JNJ-31001074

EXPERIMENTAL

Drug: JNJ-31001074

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JNJ-31001074 DRUG

Type=exact number, unit=mg, number=3, form=tablet, route=oral use. One tablet once daily for 7 days.

JNJ-31001074

Placebo DRUG

Form=tablet, route=oral administration. One tablet once daily for 7 days.

Placebo

Eligibility Criteria

• Age: 21 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• The Scripps Research Institute: collaborator

Study Sites (1)

Unknown Facility

La Jolla, California, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Mental Disorders

Interventions

bavisant

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Janssen Research & Development, LLC C. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 30, 2011
• Study Start: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: April 30, 2012

Record last verified: 2012-04

Locations

US (1)