Substance AbuseNCT01478815
Contingency Management for Persons With Severe Mental Illness
A study testing contingency management in people with Substance Abuse, run by UConn Health at 1 site in United States.
Trial summary
Contingency management is efficacious for treating cocaine abuse, but contingency management interventions have rarely been applied to patients with severe and persistent mental health problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Aug 2012
- 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
- meet DSM-IV criteria for cocaine abuse or dependence
- English speaking
- pass a brief quiz regarding study procedures to ensure understanding of the informed consent process.
Who cannot join
- dementia
- in recovery from pathological gambling
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Mental Health Affiliates, Inc.
New Britain, Connecticut, 06051
About this study
Contingency management is efficacious for treating cocaine abuse, but contingency management interventions have rarely been applied to patients with severe and persistent mental health problems. This pilot project will estimate effect sizes of contingency management for reducing cocaine use in patients receiving psychiatric care at a large community based mental health program. In total, 30 cocaine abusing patients will be randomized to one of two 8-week treatment conditions: standard care or standard care with contingency management. Patients in both conditions will provide breath and urine samples for toxicology testing twice per week. In the contingency management condition, patients will receive the opportunity to win prizes for submitting cocaine negative urine samples. The investigators expect that patients receiving contingency management will evidence reductions in cocaine use and may show improvements in psychiatric symptoms and psychosocial functioning relative to patients in standard care. Effect size estimates obtained from this study will be used to guide larger scale and longer duration evaluations of contingency management for dually diagnosed patients.
- Conditions
- Substance Abuse
- Being tested
- contingency management, Standard Care
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contingency managementBehavioural
Participants will receive the opportunity to win prizes for submitting cocaine negative urine samples.
Standard CareOther
Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Placebo comparator | Not described Receives: Other: Standard Care |
| Contingency management for abstinence from drugs | Experimental | Not described Receives: Behavioral: contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
longest continuous period of cocaine abstinence
Measured: Week 8
Secondary outcomes (1)
other drug use and psychosocial problems
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Nancy M Petry, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478815
- Sponsor's protocol ID
- 12-070-3
- Other IDs
- P30DA023918
- Status last verified
- Apr 2019
- First submitted
- 21 Nov 2011
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Petry NM, Alessi SM, Rash CJ. A randomized study of contingency management in cocaine-dependent patients with severe and persistent mental health disorders. Drug Alcohol Depend. 2013 Jun 1;130(1-3):234-7. doi: 10.1016/j.drugalcdep.2012.10.017. Epub 2012 Nov 20.
PubMed 23182410
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 Persons With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT01478815
- Acronym / sponsor ID
- 12-070-3
- Conditions
- Substance Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Nov 2011 (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.
Contingency management is efficacious for treating cocaine abuse, but contingency management interventions have rarely been applied to patients with severe and persistent mental health problems. This pilot project will estimate effect sizes of contingency management for reducing cocaine use in patients receiving psychiatric care at a large community based mental health program. In total, 30 cocaine abusing patients will be randomized to one of two 8-week treatment conditions: standard care or standard care with contingency management. Patients in both conditions will provide breath and urine samples for toxicology testing twice per week. In the contingency management condition, patients will receive the opportunity to win prizes for submitting cocaine negative urine samples. The investigators expect that patients receiving contingency management will evidence reductions in cocaine use and may show improvements in psychiatric symptoms and psychosocial functioning relative to patients in standard care. Effect size estimates obtained from this study will be used to guide larger scale and longer duration evaluations of contingency management for dually diagnosed patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Placebo comparator | Other: Standard Care |
| Contingency management for abstinence from drugs | Experimental | Behavioral: contingency management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- meet DSM-IV criteria for cocaine abuse or dependence
- English speaking
- pass a brief quiz regarding study procedures to ensure understanding of the informed consent process.
Key exclusion criteria (2 listed)
- dementia
- 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 managementParticipants will receive the opportunity to win prizes for submitting cocaine negative urine samples. | Behavioural | Contingency management for abstinence from drugs |
| Standard CareStandard Care | Other | Standard Care |
Primary outcome
longest continuous period of cocaine abstinence
Time frame: Week 8
1 secondary outcome
other drug use and psychosocial problems
Time frame: Week 8
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.
- Derived from this study: PubMed 23182410Petry NM, Alessi SM, Rash CJ. A randomized study of contingency management in cocaine-dependent patients with severe and persistent mental health disorders. Drug Alcohol Depend. 2013 Jun 1;130(1-3):234-7. doi: 10.1016/j.drugalcdep.2012.10.017. Epub 2012 Nov 20.
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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
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 in people with Substance Abuse, 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 4 inclusion and 2 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. Some participants in this study may receive a placebo. 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 continuous period of cocaine abstinence (time frame: Week 8). 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 NCT01478815, which also lists 1 linked publication.
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.