Completed

Combined Naltrexone and Psychotherapy for Alcoholism Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

naltrexone (Revia)

+ cognitive behavioral therapy

+ cue exposure treatment

DrugBehavioral
Who is being recruted

Mental Disorders+2

+ Substance-Related Disorders

+ Alcohol-Related Disorders

From 18 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
See protocol details

Summary

Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study aims to enhance alcoholism treatment. It explores how well a psychotherapy called Coping Skills Training and Cue Exposure Treatment (CSTCET) works when combined with a medication named naltrexone. The study is important as it could lead to more effective ways to treat alcoholism, potentially improving the lives of those affected by this condition. The study focuses on individuals who are dealing with alcoholism. Participants in this study first receive 2 weeks of CSTCET or a control treatment while staying at the hospital. After this, they continue with 12 consecutive weeks of either naltrexone or a placebo, which is a substance that has no therapeutic effect, as outpatients. The study then conducts follow-ups at 24, 48, and 72 weeks after the treatment is finished. The goal is to measure the effectiveness of the combined treatment over time.

NCT00000449
Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholism

Criteria

1 inclusion criteria required to participate
Meets criteria for alcohol dependence.
8 exclusion criteria prevent from participating
Current suicidality, homocidality, or psychiatric symptoms that require additional medication.
A history of psychosis or current psychotic symptoms.
History of opioid abuse in the previous year.
Females who are pregnant, nursing, or not using a reliable method of birth control.
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Brown University, Center for Alcohol and Addiction Studies

Providence, United StatesOpen Brown University, Center for Alcohol and Addiction Studies in Google Maps
CompletedOne Study Center