Alcohol DependenceNCT00408161
Contingency Management for Chronic Recidivist Alcohol-Dependent Patients
A study testing Contingency Management and standard case management treatment in people with Alcohol Dependence, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in reducing in-patient detoxification services for chronic recidivist alcohol-dependent patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Contingency Management and standard case management treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- Four or more inpatient alcohol detoxifications in the previous 12 months
- current diagnosis of DSM-IV alcohol dependence
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in reducing in-patient detoxification services for chronic recidivist alcohol-dependent patients.
Read the detailed description
This study evaluates the efficacy of prize contingency management (CM) in reducing in-patient detoxification services for chronic recidivist alcohol-dependent patients. 116 alcohol-dependent patients who have received 4 or more alcohol detoxifications in a calendar year will be randomly assigned to one of two 6-month treatment conditions: standard case management treatment, or standard case management treatment plus CM. In the CM condition, patients earn the chance to win prizes by submitting negative breath samples and by complying with steps toward treatment goals, such as attending outpatient substance abuse treatment services, attending appointments with low income housing programs, or complying with outpatient psychiatric treatment. Treatment services received, alcohol and drug use, psychosocial functioning, and HIV risk behaviors will be measured pre-treatment and at months 1, 3, and 6 (post-treatment), and at follow-ups scheduled for 9, 12, and 18 months after intake.
- Conditions
- Alcohol Dependence
- Being tested
- Contingency Management, standard case management treatment
- Keywords
- Contingency Management, Alcohol Dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Also called CM
prize contingency management (CM) -- 6-month treatment plus standard case management treatment and follow-ups at 9, 12, and 18 months after intake
standard case management treatmentBehavioural
6-month treatment standard case management treatment, and follow-ups scheduled at 9, 12, and 18 months after intake.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | prize contingency management (CM) plus standard case management treatment -- patients earn the chance to win prizes by submitting negative breath samples and by complying with steps toward treatment goals Receives: Behavioral: Contingency Management |
| 2 | Active comparator | standard case management treatment Receives: Behavioral: standard case management treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of detoxifications
Measured: 9, 12, and 18 months after intake
objective alcohol use
Measured: 9, 12, and 18 months after intake
self-reported alcohol use
Measured: 9, 12, and 18 months after intake
Secondary outcomes (4)
ASI composite scores
Measured: 9, 12, and 18 months after intake
BSI scores
Measured: 9, 12, and 18 months after intake
HRBS scores
Measured: 9, 12, and 18 months after intake
objective drug use
Measured: 9, 12, and 18 months after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startAug 2003
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies 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
- 104 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
- Sponsor
- Investigators
- Nancy M Petry, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408161
- Sponsor's protocol ID
- NIAAA-PET03510
- Other IDs
- NIH Grant P50-AA03510
- Status last verified
- Apr 2019
- First submitted
- 4 Dec 2006
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management for Chronic Recidivist Alcohol-Dependent Patients
- ClinicalTrials.gov ID
- NCT00408161
- Acronym / sponsor ID
- NIAAA-PET03510
- Conditions
- Alcohol Dependence
- Keywords
- Contingency Management, Alcohol Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Aug 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in reducing in-patient detoxification services for chronic recidivist alcohol-dependent patients.
Detailed description
This study evaluates the efficacy of prize contingency management (CM) in reducing in-patient detoxification services for chronic recidivist alcohol-dependent patients. 116 alcohol-dependent patients who have received 4 or more alcohol detoxifications in a calendar year will be randomly assigned to one of two 6-month treatment conditions: standard case management treatment, or standard case management treatment plus CM. In the CM condition, patients earn the chance to win prizes by submitting negative breath samples and by complying with steps toward treatment goals, such as attending outpatient substance abuse treatment services, attending appointments with low income housing programs, or complying with outpatient psychiatric treatment. Treatment services received, alcohol and drug use, psychosocial functioning, and HIV risk behaviors will be measured pre-treatment and at months 1, 3, and 6 (post-treatment), and at follow-ups scheduled for 9, 12, and 18 months after intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Contingency Managementprize contingency management (CM) plus standard case management treatment -- patients earn the chance to win prizes by submitting negative breath samples and by complying with steps toward treatment goals |
| 2 | Active comparator | Behavioral: standard case management treatmentstandard case management treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or older
- Four or more inpatient alcohol detoxifications in the previous 12 months
- current diagnosis of DSM-IV alcohol dependence
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Contingency ManagementAlso: CMprize contingency management (CM) -- 6-month treatment plus standard case management treatment and follow-ups at 9, 12, and 18 months after intake | Behavioural | 1 |
| standard case management treatment6-month treatment standard case management treatment, and follow-ups scheduled at 9, 12, and 18 months after intake. | Behavioural | 2 |
Primary outcome
number of detoxifications
Time frame: 9, 12, and 18 months after intake
objective alcohol use
Time frame: 9, 12, and 18 months after intake
self-reported alcohol use
Time frame: 9, 12, and 18 months after intake
4 secondary outcomes
ASI composite scores
Time frame: 9, 12, and 18 months after intake
BSI scores
Time frame: 9, 12, and 18 months after intake
HRBS scores
Time frame: 9, 12, and 18 months after intake
objective drug use
Time frame: 9, 12, and 18 months after intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
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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.
Nancy M Petry, PhD 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 Contingency Management and standard case management treatment in people with Alcohol Dependence, 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 3 inclusion and 1 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 9 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of detoxifications (time frame: 9, 12, and 18 months after intake). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2019.