Targeted Naltrexone for Problem Drinkers

NCT00369408 | Completed Phase 4 DMC

• 2 other identifiers: 03-107-2NIAAA-KRA-P50-03510
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether naltrexone, combined with brief coping skills therapy, is effective in the treatment of heavy drinking.

Conditions

Alcoholism; Alcohol Drinking; Alcohol Dependence

Keywords

Randomized Trial; Medication for Heavy Drinking; Naltrexone Treatment; Daily vs. Targeted Administration

Outcome Measures

Primary Outcomes (1)

• Drinking days and heavy drinking days

  12-week trial; 3 and 6 months post-treatment follow-up

Secondary Outcomes (2)

• Alcohol-related problems

  12-week trial; 3 and 6 months post-treatment follow-up

• Biological measures of alcohol consumption (i.e., serum GGTP and CDT)

  12-week trial; 3 and 6 months post-treatment follow-up

Study Arms (2)

1

EXPERIMENTAL

naltrexone (50 mg orally) for 12-week treatment period

Drug: Naltrexone

2

PLACEBO COMPARATOR

placebo for 12-week treatment period

Drug: placebo

Interventions

Naltrexone DRUG

naltrexone (50 mg orally) for 12-week treatment period; 3 and 6 months post-treatment follow-up

Also known as: ReVia

1

placebo DRUG

placebo for 12-week treatment period; 3 and 6 months post-treatment follow-up

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female outpatients 18-70 years of age.
• Participants will have an average weekly ethanol consumption of \>=24 standard drinks for men, or \>=18 standard drinks for women (i.e., substantially in excess of non-hazardous drinking levels).
• Participants will be able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
• If a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or who are less than two years postmenopausal), participant must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment.
• Participants will be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels).

You may not qualify if:

• Participants who have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including total bilirubin elevations of \>110% or ALT or AST elevations \>300% the upper limit of normal or have a diagnosis of Hepatitis B or C infection or AIDS (given the potential for adverse effects of naltrexone on liver function).
• Participants who have a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality states, organic mood or mental disorders, or substantial suicide or violence risk) on the basis of history or psychiatric examination.
• Participants who have a current Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) diagnosis of drug dependence (other than nicotine dependence) or a lifetime DSM-IV diagnosis of opioid dependence.
• Participants who have a current DSM-IV diagnosis of alcohol dependence that is clinically severe.
• Participants who have used opioids or other psychoactive medications regularly in the month prior to study enrollment.
• Participants who have a history of hypersensitivity to naltrexone.
• Participants who are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug.

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (1)

• Kranzler HR, Tennen H, Armeli S, Chan G, Covault J, Arias A, Oncken C. Targeted naltrexone for problem drinkers. J Clin Psychopharmacol. 2009 Aug;29(4):350-7. doi: 10.1097/JCP.0b013e3181ac5213.

  PMID: 19593174 RESULT

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Henry R. Kranzler, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: June 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: March 1, 2008
• Last Updated: June 20, 2011

Record last verified: 2011-06

Locations

US (1)