Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone

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.

Study Overview

• Status: Completed
• Conditions: Alcoholism
• Intervention / Treatment: Drug: Acamprosate; Drug: Naltrexone; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • The Scripps Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3	Drug: Placebo; Matched placebo capsule, 1 week duration; Other Names: Sugar pill
Active Comparator: 1; Acamprosate	Drug: Acamprosate; Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration; Other Names: Campral
Active Comparator: 2; Naltrexone	Drug: Naltrexone; 50mg capsule, Once daily, 1 week duration; Other Names: ReVia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period	The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Standard Drinks Per Week at 1 Week	Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.	1 week
Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1	The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3.	1 week
Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1	The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score.	1 week
Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1	The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score.	2 weeks

Collaborators and Investigators

• Sponsor: The Scripps Research Institute
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 10, 2008
• First Posted (Estimate): April 11, 2008

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone; Acamprosate
• Other Study ID Numbers: AA012602; R01AA012602 (U.S. NIH Grant/Contract)