Medication Development in Alcoholism: Acamprosate Versus Naltrexone

NCT00656630 | Completed Phase 2 Results

• 2 other identifiers: AA012602R01AA012602
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change From Baseline in Standard Drinks Per Week at 1 Week

  1 week

• Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1

  1 week

• Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1

  1 week

• Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1

  2 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Acamprosate

Drug: Acamprosate

2

ACTIVE COMPARATOR

Naltrexone

Drug: Naltrexone

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acamprosate DRUG

Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration

Also known as: Campral

1

Naltrexone DRUG

50mg capsule, Once daily, 1 week duration

Also known as: ReVia

2

Placebo DRUG

Matched placebo capsule, 1 week duration

Also known as: Sugar pill

3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Scripps Research Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The Scripps Research Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Acamprosate; Naltrexone; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Barbara J. Mason, Ph.D.-Principal Investigator
• Organization: The Scripps Research Institute

mason@scripps.edu

858784-7328

Study Officials

• Barbara J Mason, Ph.D.

  The Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 11, 2008
• Study Start: December 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (1)