Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent

NCT ID: NCT01842503

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GET 73

300 mg (3 capsules) tid for 3 days

Group Type: ACTIVE_COMPARATOR

GET 73

Intervention Type: DRUG

300 mg tid on 3 days cycle

inactive ingredients capsule

3 capsules tid for 3 days

Group Type: PLACEBO_COMPARATOR

inactive ingredients capsule

Intervention Type: DRUG

3 capsules tid on 3 days cycle

Interventions

GET 73

300 mg tid on 3 days cycle

Intervention Type: DRUG

inactive ingredients capsule

3 capsules tid on 3 days cycle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• male or female subjects, between 21 and 65 years old (inclusive);
• participants must meet criteria for current Diagnostic and Statistical Manual (DSM-IV)diagnosis of alcohol dependence,supported by the structured clinical interview for DSM-IV Axis I Disorders Patient Edition;
• participants must meet criteria for heavy drinking, defined as averaging

• 4 drinks/day for women and ≥5 drinks/day for men during a 30-day period within the 90 days prior to screening evaluation;
• participants must be in good health as confirmed by medical history, physical examination, ECG, lab tests;
• females must be postmenopausal for at least one year or surgically sterile. Otherwise, females will be excluded (even if they are using any kind of birth control). Proof (medical records, certification from an medical doctor) of surgical sterility will be required. Certification of postmenopausal for at least 1 year and postmenopausal levels of FSH will also be required to be into the study;
• participants must be willing to take oral medication and adhere to the study procedures;
• participants must give their consent to enter the study by signing the informed consent form.

Exclusion Criteria

• individuals seeking treatment for alcohol dependence;
• positive urine drug screen at baseline for positive drug screen for the following: opioids, benzodiazepines, cocaine, methamphetamine or any other stimulants. A urine drug screen may be repeated once and must test negative before randomization;
• individuals diagnosed with a current substance dependence, other than alcohol or nicotine;
• meet DSM-IV Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar disorder, or other psychoses;
• Subjects taking any psychoactive medication that in the opinion of the subjects primary care physician, cannot be discontinued at least 14 days prior to being randomized;
• an active illness within the past 6 months of Visit 1 that meet the DSM-IV criteria for a diagnosis of Major Depressive Disorder or Anxiety Disorder;
• subjects with a history of suicide attempts and/or at risk for suicide will be excluded, based on the Structured Clinical Interview Disorders assessment and on the Investigators' evaluation;
• clinically significant medical abnormalities (i.e., unstable hypertension, clinically significant abnormal ECG, bilirubin > 150% of the upper normal limit, alanine aminotransferase or aspartate aminotransferase elevations >300% the upper normal limit, estimated creatinine clearance ≤ 60 dl/min);
• current use of any medications prescribed to reduce alcohol use e.g. naltrexone, acamprosate, disulfiram or topiramate;
• concomitant use of cytochromeP450 2C19 substrates; assumption of cytochromeP450 2C19 and cytochromeP450 3A4 inhibitors or inducers in the 14 days before dosing;
• individuals with a reasonable expectation of being institutionalized during the course of the trial;
• participants who have significant alcohol withdrawal symptoms, defined as a Clinical Institute Withdrawal Assessment >10;
• history of seizures (e.g. epilepsy), including alcohol-related seizures;
• history of delirium tremens;
• subjects who have participated in any behavioral and/or pharmacological study within the past 30 days;
• history of delirium tremens.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Voisin Consulting, Inc.

INDUSTRY

Sponsor Role: collaborator

Latis S.r.l.

INDUSTRY

Sponsor Role: collaborator

Quotient Bioresearch

INDUSTRY

Sponsor Role: collaborator

Laboratorio Farmaceutico Ct S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert M. Swift, M.D., R.Ph.

Role: PRINCIPAL_INVESTIGATOR

Roger Williams Medical Center

Locations

Roger Williams Medical Center

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

2012-005515-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

73CT-2-03

Identifier Type: -

Identifier Source: org_study_id