Trials / Completed
CompletedNCT01842503
Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent
A Phase 1b/2a, Cross-over, Randomised, Double-blind, Placebo Controlled Study to Investigate the Safety and Pharmacodynamic Effects of GET 73 in Alcohol Dependent Subjects
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Laboratorio Farmaceutico Ct S.r.l. · Industry
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics (intoxication and sedation)and safety profile in alcohol-dependent individuals.To evaluate whether GET 73, as compared to placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink during the cue reactivity session and results in lower quantity of alcohol consumed during an alcohol self-administration session.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GET 73 | 300 mg tid on 3 days cycle |
| DRUG | inactive ingredients capsule | 3 capsules tid on 3 days cycle |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
- First posted
- 2013-04-29
- Last updated
- 2019-04-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01842503. Inclusion in this directory is not an endorsement.