Phase 2
Completed N=68
Medication Development in Alcoholism: Acamprosate Versus Naltrexone
Alcoholism
Source: ClinicalTrials.gov NCT00656630 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period — 2.12; 3.40; 5.86; 1.65 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period |
2.12; 3.40; 5.86; 1.65; 2.99; 4.22 | — |
| SECONDARY Change From Baseline in Standard Drinks Per Week at 1 Week |
44.90; 47.02; 48.87; 24.37; 25.79; 21.51 | — |
| SECONDARY Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1 |
4.40; 4.04; 3.53; 4.75; 3.84; 4.94 | — |
| SECONDARY Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1 |
4.50; 4.74; 4.25; 4.69; 4.57; 4.38 | — |
| SECONDARY Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1 |
3.80; 3.81; 3.99; 3.36; 3.69; 3.51 | — |
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
Data sourced from ClinicalTrials.gov (NCT00656630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.