MedTrace Logo

Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent

NCT01842503 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-04-10

No results posted yet for this study

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

  • Alcohol Dependence

Interventions

DRUG

GET 73

300 mg tid on 3 days cycle

DRUG

inactive ingredients capsule

3 capsules tid on 3 days cycle

Sponsors & Collaborators

  • Voisin Consulting, Inc.

    collaborator INDUSTRY

  • Latis S.r.l.

    collaborator INDUSTRY

  • Quotient Bioresearch

    collaborator INDUSTRY

  • Laboratorio Farmaceutico Ct S.r.l.

    lead INDUSTRY

Principal Investigators

  • Robert M. Swift, M.D., R.Ph. · Roger Williams Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01842503 on ClinicalTrials.gov