Cocaine DependenceNCT00249535
Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients - 2
A study testing Contingency management in people with Cocaine Dependence, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this study is to compare voucher-based contingency management (CM) procedures to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus usual magnitude prize CM, (c) standard treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Dependence
- 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
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jul 2011
- 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 cocaine dependence
- received methadone treatment at the clinic for at least 3 months
- on a stable dose of methadone (no changes in dosing) for at least one month and not presently requesting a dose alteration
- submitted one or more clinic-collected cocaine positive urine samples in the previous 3 months
- English speaking
- pass a brief quiz related to understanding of the informed consent form
Who cannot join
- have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk)
- have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975)
- are in recovery from pathological gambling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients
The purpose of this study is to compare voucher-based contingency management (CM) procedures to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus usual magnitude prize CM, (c) standard treatment plus higher magnitude prize CM, or (d) standard treatment plus voucher CM. Urine and breath samples are collected 2-3x/week for 14 weeks. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.
- Conditions
- Cocaine Dependence
- Being tested
- Contingency management
- Keywords
- Substance Abuse, Contingency Management
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
Rewards (prizes) for abstinence
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | standard treatment plus usual magnitude prize CM Receives: Behavioral: Contingency management |
| 2 | Experimental | standard treatment plus higher magnitude prize CM Receives: Behavioral: Contingency management |
| 3 | Experimental | standard treatment plus voucher CM Receives: Behavioral: Contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine 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 posted7 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine 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
- Single group
- Masking
- None (open label)
- Enrolment
- 240 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 Petry, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249535
- Sponsor's protocol ID
- NIDA-13444-2
- Other IDs
- R01DA013444
- Status last verified
- Mar 2012
- First submitted
- 3 Nov 2005
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients
- ClinicalTrials.gov ID
- NCT00249535
- Acronym / sponsor ID
- NIDA-13444-2
- Conditions
- Cocaine Dependence
- Keywords
- Substance Abuse, Contingency Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Nov 2005 (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 compare voucher-based contingency management (CM) procedures to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus usual magnitude prize CM, (c) standard treatment plus higher magnitude prize CM, or (d) standard treatment plus voucher CM. Urine and breath samples are collected 2-3x/week for 14 weeks. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Contingency managementstandard treatment plus usual magnitude prize CM |
| 2 | Experimental | Behavioral: Contingency managementstandard treatment plus higher magnitude prize CM |
| 3 | Experimental | Behavioral: Contingency managementstandard treatment plus voucher CM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age > 18 years
- current DSM-IV diagnosis of cocaine dependence
- received methadone treatment at the clinic for at least 3 months
- on a stable dose of methadone (no changes in dosing) for at least one month and not presently requesting a dose alteration
- submitted one or more clinic-collected cocaine positive urine samples in the previous 3 months
Key exclusion criteria (3 listed)
- have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk)
- have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975)
- are 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 managementRewards (prizes) for abstinence | Behavioural | 1, 2, 3 |
Primary outcome
Cocaine 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 30 Mar 2012.
Related trials for Cocaine Dependence
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
Active, not recruitingPhase 1
AAV8-hCocH for Cocaine Use Disorder
Cocaine Dependence, in Remission
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 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 Cocaine 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 7 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 30 Mar 2012. 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?
Cocaine use (time frame: baseline and each follow-up). 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 30 Mar 2012.