Clinical trial NCT00656630: Medication Development in Alcoholism: Acamprosate Versus Naltrexone
Official title: Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2008-04-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence.

Detailed description: This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues relative to placebo in early abstinence.

Eligibility criteria: Inclusion Criteria:

* Males or females ≥ 18 and ≤ 55 years of age
* Meets Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) criteria for current alcohol dependence
* Does not desire treatment
* Alcohol free, as verified by breath alcohol concentration, with a Clinical Institute Withdrawal Assessment (CIWA) ≤ 8, at the time of testing, with no evidence of drinking for at least 3 days but no more than 7 days prior to the cue reactivity session
* Able to complete and understand questionnaires and study procedures in English
* Verbal I.Q. estimate ≥ 85
* Signed informed consent

Exclusion Criteria:

* Currently meets DSM-IV criteria for dependence on substances other than alcohol or nicotine
* Significant medical disorders that will increase potential risk or interfere with study participation
* Sexually active women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
* Meets DSM-IV criteria for a major Axis I disorder, including depression or anxiety disorders
* Treatment within the month prior to screening with investigational medications or those which may influence drinking outcome, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), antidepressants or other psychotropic agents
* Chronic treatment with any narcotic-containing medications during the previous month or evidence of current opiate use
* Liver function tests more than three times normal or elevated bilirubin
* No fixed domicile and/or no availability by telephone or beeper
* Current involvement in or plans for treatment prior to study completion
* Patients who have a history of adverse drug reactions to the study drugs or their ingredients
* Failure to take double-blind medication as prescribed
* Inability to understand or comply with the provisions of the protocol or consent form

Primary outcomes:
measure: Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period
timeFrame: 1 week
Secondary outcomes:
measure: Change From Baseline in Standard Drinks Per Week at 1 Week
timeFrame: 1 week
measure: Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1
timeFrame: 1 week
measure: Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1
timeFrame: 1 week
measure: Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1
timeFrame: 2 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: