Completed

Naltrexone and Substance Abuse Counseling for Alcohol Dependence in Rural Settings

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

naltrexone (Revia)

Drug
Who is being recruted

Mental Disorders+2

+ Substance-Related Disorders

+ Alcohol-Related Disorders

Over 18 Years
+11 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

The study focuses on understanding the effectiveness of a medication called Naltrexone in combination with substance abuse counseling therapy, compared to counseling therapy alone, in a rural, non-academic setting. This research aims to help individuals struggling with alcohol dependence. The importance of this study lies in its potential to improve treatment services for alcohol dependence by assessing the impact of adding Naltrexone to the current treatment options. It also aims to understand how this addition affects service utilization and cost in a real-world clinical setting, building upon previous research conducted in clinical trials.

NCT00000445
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

300 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.

Over 18 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

5 inclusion criteria required to participate
Consent to random assignment and be willing to commit to possible medication treatment and research follow-up
Meets criteria for alcohol dependence (within the past 3 months)
Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse
Must be able to provide an informed consent
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6 exclusion criteria prevent from participating
Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion
Currently being prescribed naltrexone
Hepatocellular disease
Known sensitivity or allergy to naltrexone
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

Center for Drug and Alcohol Programs, Medical University of South Carolina

Charleston, United StatesOpen Center for Drug and Alcohol Programs, Medical University of South Carolina in Google Maps
CompletedOne Study Center