|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 2, 1999 | ||||
| Last Updated Date | November 26, 2007 | ||||
| Start Date ICMJE | September 1992 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00000456 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Behavioral Therapy Plus Naltrexone for Alcoholism | ||||
| Official Title ICMJE | Comparison of Cognitive Behavioral Therapy and Motivational Enhancement Therapy Plus Naltrexone for Alcoholism | ||||
| Brief Summary | This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol. |
||||
| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | Anton RF, Moak DH, Latham P, Waid LR, Myrick H, Voronin K, Thevos A, Wang W, Woolson R. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005 Aug;25(4):349-57. | ||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 160 | ||||
| Completion Date | August 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 21 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00000456 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NIAAAANT09568 | ||||
| Study Sponsor ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||||
| Verification Date | November 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||