Alcohol AbuseDurationNCT00732342
Contingency Management Treatment Duration
A study testing Contingency Management in people with Alcohol Abuse, run by UConn Health at 5 sites in United States.
Trial summary
310 alcohol abusing or dependent patients beginning intensive outpatient day treatment at community-based clinics will be randomly assigned to one of four conditions: (a) standard treatment as usual (ST) at the clinic without contingency management (CM); (b) standard treatment with contingency management for 12 weeks… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2008to May 2015
- 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
- current DSM-IV diagnosis of alcohol abuse or dependence
- willing to sign informed consent and able to pass an informed consent quiz
Who cannot join
- serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination
- current DSM-IV diagnosis of opioid dependence
- in recovery from pathological gambling
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Prospect House
Bridgeport, Connecticut, 06604
Alcohol and Drug Recovery Centers, Inc.
Hartford, Connecticut, 06112
The Hospital of Central Connecticut at New Britain General
New Britain, Connecticut, 06050
Carlson Recovery Center
Springfield, Massachusetts, 01199
Morris Foundation
Waterbury, Connecticut, 06702
About this study
310 alcohol abusing or dependent patients beginning intensive outpatient day treatment at community-based clinics will be randomly assigned to one of four conditions: (a) standard treatment as usual (ST) at the clinic without contingency management (CM); (b) standard treatment with contingency management for 12 weeks with a 0.5 probability of winning prizes for each negative sample submitted; (c) standard treatment with contingency management for 24 weeks with a 0.34 probability of winning prizes for each negative sample submitted; or (d) standard treatment with contingency management for 24 weeks with a 0.5 probability of winning prizes for each negative sample submitted. We expect that contingency management will decrease alcohol use to a greater extent than non-contingency management treatment, and that availability of contingency management for 24 weeks may result in longer term benefits than 12 week exposure to contingency management. This study will be the first to evaluate the effects of probability of winning prizes on response to contingency management.
- Conditions
- Alcohol Abuse
- Being tested
- Contingency Management
- Keywords
- Alcohol Abuse, Contingency Management, Treatment Duration
- 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
Prizes given for targeted behavior of abstinence
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Standard Treatment |
| 2 | Experimental | Standard Treatment with Contingency Management for 12 weeks with a 0.5 probability of winning prizes for each negative sample submitted Receives: Behavioral: Contingency Management |
| 3 | Experimental | Standard Treatment with Contingency Management for 24 weeks with a 0.34 probability of winning prizes for each negative sample submitted Receives: Behavioral: Contingency Management |
| 4 | Experimental | Standard Treatment with Contingency Management for 24 weeks with a 0.5 probability of winning prizes for each negative sample submitted Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
longest duration of negative breath samples submitted
Measured: active phase and throughout follow-up phase
Secondary outcomes (1)
subjective reports of alcohol use
Measured: baseline and each follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 310 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, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732342
- Sponsor's protocol ID
- 08-053-2
- Other IDs
- P60AA003510
- Acronym
- Duration
- Status last verified
- Apr 2019
- First submitted
- 7 Aug 2008
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
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 Treatment Duration
- ClinicalTrials.gov ID
- NCT00732342
- Acronym / sponsor ID
- Duration / 08-053-2
- Conditions
- Alcohol Abuse
- Keywords
- Alcohol Abuse, Contingency Management, Treatment Duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2008
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Aug 2008 (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.
310 alcohol abusing or dependent patients beginning intensive outpatient day treatment at community-based clinics will be randomly assigned to one of four conditions: (a) standard treatment as usual (ST) at the clinic without contingency management (CM); (b) standard treatment with contingency management for 12 weeks with a 0.5 probability of winning prizes for each negative sample submitted; (c) standard treatment with contingency management for 24 weeks with a 0.34 probability of winning prizes for each negative sample submitted; or (d) standard treatment with contingency management for 24 weeks with a 0.5 probability of winning prizes for each negative sample submitted. We expect that contingency management will decrease alcohol use to a greater extent than non-contingency management treatment, and that availability of contingency management for 24 weeks may result in longer term benefits than 12 week exposure to contingency management. This study will be the first to evaluate the effects of probability of winning prizes on response to contingency management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Standard Treatment |
| 2 | Experimental | Behavioral: Contingency ManagementStandard Treatment with Contingency Management for 12 weeks with a 0.5 probability of winning prizes for each negative sample submitted |
| 3 | Experimental | Behavioral: Contingency ManagementStandard Treatment with Contingency Management for 24 weeks with a 0.34 probability of winning prizes for each negative sample submitted |
| 4 | Experimental | Behavioral: Contingency ManagementStandard Treatment with Contingency Management for 24 weeks with a 0.5 probability of winning prizes for each negative sample submitted |
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
- current DSM-IV diagnosis of alcohol abuse or dependence
- willing to sign informed consent and able to pass an informed consent quiz
Key exclusion criteria (3 listed)
- serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination
- current DSM-IV diagnosis of opioid dependence
- in recovery from pathological gambling
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 ManagementPrizes given for targeted behavior of abstinence | Behavioural | 2, 3, 4 |
Primary outcome
longest duration of negative breath samples submitted
Time frame: active phase and throughout follow-up phase
1 secondary outcome
subjective reports of alcohol use
Time frame: baseline and each follow-up
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, Ph.D. principal investigator
UConn Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Alcohol Abuse, run by UConn Health at 5 sites 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 3 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 5 sites 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?
longest duration of negative breath samples submitted (time frame: active phase and throughout follow-up phase). 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.