Last reviewed · How we verify
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.
Details
| Lead sponsor | The Scripps Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 68 |
| Start date | 2007-12 |
| Completion | 2010-01 |
Conditions
- Alcoholism
Interventions
- Acamprosate
- Naltrexone
- Placebo
Primary outcomes
- Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period — 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.
Countries
United States