Alcohol ConsumptionNCT01129804
Network Support for Alcohol Treatment 2
A study testing Coping Skills Training in people with Alcohol Consumption, run by UConn Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Coping Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 yo
- meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: 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.
- Conditions
- Alcohol Consumption
- Being tested
- Coping Skills Training
- Keywords
- Alcohol dependence, Network Support, Cognitive-behavioral treatment, Relapse prevention, Consequences of drinking, Social network development
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Skills TrainingBehavioural
Patients in both treatments will be taught skills to help them keep from drinking.
| Study group | Role | What they receive |
|---|---|---|
| Network Support | Experimental | 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. Receives: Behavioral: Coping Skills Training |
| Packaged Cognitive-Behavioral Treatment | Active comparator | 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. Receives: Behavioral: Coping Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion Days Abstinent (PDA)
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.
Measured: Every 3 months out to 2 years
Secondary outcomes (1)
Social Network Change
Network Support for Abstinence. Minimum score=0; Maximum score =1. Higher scores indicate greater support for abstinence.
Measured: assessed every 6 months out to 2 years, mean change over 2 years reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Mark Litt, UConn Health
- Investigators
- Mark D Litt, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129804
- Sponsor's protocol ID
- 09-050
- Other IDs
- R01AA012827
- Status last verified
- Oct 2021
- First submitted
- 21 May 2010
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 17663609Litt 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.
PubMed 19309183Litt 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.
PubMed 29575339Litt 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.
PubMed 27354234
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Support for Alcohol Treatment: Mechanisms and Effectiveness
- ClinicalTrials.gov ID
- NCT01129804
- Acronym / sponsor ID
- 09-050
- Conditions
- Alcohol Consumption
- Keywords
- Alcohol dependence, Network Support, Cognitive-behavioral treatment, Relapse prevention, Consequences of drinking, Social network development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Network Support | Experimental | Behavioral: Coping Skills TrainingNetwork 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. |
| Packaged Cognitive-Behavioral Treatment | Active comparator | Behavioral: Coping Skills TrainingThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 yo
- meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping Skills TrainingPatients in both treatments will be taught skills to help them keep from drinking. | Behavioural | Network Support, Packaged Cognitive-Behavioral Treatment |
Primary outcome
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.
1 secondary outcome
Social Network Change
Time frame: assessed every 6 months out to 2 years, mean change over 2 years reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17663609Litt 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.
- Results publication: PubMed 19309183Litt 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.
- Derived from this study: PubMed 29575339Litt 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.
- Derived from this study: PubMed 27354234Litt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Litt, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Skills Training in people with Alcohol Consumption, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion Days Abstinent (PDA) (time frame: Every 3 months out to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129804, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.