- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01129804
Network Support for Alcohol Treatment 2
Network Support for Alcohol Treatment: Mechanisms and Effectiveness
The Network Support project is part of an ongoing effort to improve treatment for alcohol dependent patients. The Network Support Project is designed to help patients change their social network from one that reinforces drinking behavior to one that reinforces sobriety.
160 patients will be assigned to one of two treatments. Each of the treatments will last 12 weeks. The first is a Network Support (NS) treatment designed to help patients develop new acquaintances and social networks. It is expected that alcohol dependent patients will benefit from increasing their contact with non-drinking people. This NS condition will be compared to a packaged CBT program for alcoholics (PCBT) that is designed to teach a number of skills to help people stop drinking, but does not address social networks per se.
In order to better understand what is happening to the investigators patients, the investigators will be using daily computerized telephone calls to ask about people's experiences. This will be done both before and after treatment. Patients will also be asked to participate in follow-up interviews every 3 months for 2 years following the end of treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 yo
- meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence
Exclusion Criteria:
- acute medical or psychiatric problems that require inpatient treatment (e.g., acute psychosis, or suicide/homicide risk)
- reading ability below the fifth grade level
- lack of reliable transportation to the treatment site, or excessive commuting distance
- inability to understand English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Network Support
Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence.
In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers.
These activities would be determined by the patient, with help from the therapist.
Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking.
In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.
|
Patients in both treatments will be taught skills to help them keep from drinking.
|
|
Active Comparator: Packaged Cognitive-Behavioral Treatment
The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.
|
Patients in both treatments will be taught skills to help them keep from drinking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion Days Abstinent (PDA)
Time Frame: Every 3 months out to 2 years
|
PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking.
PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks.
|
Every 3 months out to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Network Change
Time Frame: assessed every 6 months out to 2 years, mean change over 2 years reported
|
Network Support for Abstinence.
Minimum score=0; Maximum score =1.
Higher scores indicate greater support for abstinence.
|
assessed every 6 months out to 2 years, mean change over 2 years reported
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark D Litt, Ph.D., UCONN Health
Publications and helpful links
General Publications
- Litt MD, Kadden RM, Kabela-Cormier E, Petry N. Changing network support for drinking: initial findings from the network support project. J Consult Clin Psychol. 2007 Aug;75(4):542-55. doi: 10.1037/0022-006X.75.4.542.
- Litt MD, Kadden RM, Kabela-Cormier E, Petry NM. Changing network support for drinking: network support project 2-year follow-up. J Consult Clin Psychol. 2009 Apr;77(2):229-42. doi: 10.1037/a0015252.
- Litt MD, Kadden RM, Tennen H. Treatment response and non-response in CBT and Network Support for alcohol disorders: targeted mechanisms and common factors. Addiction. 2018 Aug;113(8):1407-1417. doi: 10.1111/add.14224. Epub 2018 Apr 20.
- Litt MD, Kadden RM, Tennen H, Kabela-Cormier E. Network Support II: Randomized controlled trial of Network Support treatment and cognitive behavioral therapy for alcohol use disorder. Drug Alcohol Depend. 2016 Aug 1;165:203-12. doi: 10.1016/j.drugalcdep.2016.06.010. Epub 2016 Jun 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-050
- R01AA012827 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Consumption
-
The University of Hong KongActive, not recruitingExcessive Alcohol ConsumptionHong Kong
-
Centre for Addiction and Mental HealthUniversity of HoustonCompleted
-
Centre for Addiction and Mental HealthCanadian Institutes of Health Research (CIHR)CompletedAlcohol Consumption | Hazardous Alcohol ConsumptionCanada
-
Wayne State UniversityCompleted
-
Institut national de prevention et d'education...CompletedHazardous Alcohol Consumption
-
International Agency for Research on CancerUniversidad de Murcia; Federico II University; University of Tromso; Imperial College... and other collaboratorsCompletedNo Condition, Focus: Metabolites of Alcohol Consumption
-
Denver Health and Hospital AuthorityMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.CompletedModerate Alcohol Consumption (1-3 Drinks Per Day)
-
University of WashingtonNational Institutes of Health (NIH); National Institute on Aging (NIA); Seattle...Active, not recruitingMild to Heavy Alcohol ConsumptionUnited States
-
Jordi Gol i Gurina FoundationSocietat Catalana de Medicina Familiar i Comunitària (CAMFIC); Associació Catalana... and other collaboratorsUnknownAlcohol Consumption | Traffic Accident | Risk Perception of Driving After Alcohol ConsumptionSpain
-
Technische Universität DresdenCharite University, Berlin, GermanyCompletedHigh-risk Alcohol Consumption Pattern | Low-risk Alcohol Consumption PatternGermany
Clinical Trials on Coping Skills Training
-
Ohio UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedCardiorespiratory FailureUnited States
-
Duke UniversityCompletedPCST-Full (Pain Coping Skills Training) | PCST-BriefUnited States
-
Duke UniversityCompletedHematopoietic Neoplasms (Leukemia, Lymphoma, Multiple Myeloma)United States
-
Children's Hospital and Health System Foundation...University of Wisconsin, MadisonCompletedEpilepsy | Asthma | Spina Bifida | Rheumatologic Conditions (JRA,Lupus)United States
-
Hacettepe UniversityEnrolling by invitation
-
Istituto Auxologico ItalianoCompletedPsychological StressItaly
-
University of California, San FranciscoNational Institute of Nursing Research (NINR); University of San Francisco; Donaldina... and other collaboratorsCompletedType 2 Diabetes MellitusUnited States
-
Duke UniversityCompletedMobile Pain Coping Skills Training | In Person Pain Coping Skills TrainingUnited States
-
Saglik Bilimleri UniversitesiCompleted