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Completed

NCT Number: NCT00656630

Medication Development 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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Scripps Research Institute

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acamprosate

Drug

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

Other names: Campral

Naltrexone

Drug

50mg capsule, Once daily, 1 week duration

Other names: ReVia

Placebo

Drug

Matched placebo capsule, 1 week duration

Other names: Sugar pill

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

    Time frame: 1 week

    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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 1 week

    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.

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

    Time frame: 1 week

    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.

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

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

The Scripps Research Institute

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 11, 2008
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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