Substance AbuseNCT00249548
Low-Cost Contingency Management for Hispanic Outpatients - 3
A study testing Contingency management in people with Substance Abuse, run by National Institute on Drug Abuse (NIDA).
Trial summary
The purpose of this study is to evaluate the effectiveness of a lower-cost contingency management (CM) procedure in Hispanic substance abusing outpatients. Thirty individuals meeting DSM-IV criteria for substance dependence receive one of two conditions: (a) standard treatment, or (b) standard treatment plus prize CM. 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
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Jan 2006
- 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 substance dependence.
Who cannot join
- have a 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
- have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975)
- DSM-IV diagnosis of pathological gambling
- plans to move from the Hartford are within 9 months.
About this study
Official title: Low-Cost Contingency Management for Hispanic Outpatients
The purpose of this study is to evaluate the effectiveness of a lower-cost contingency management (CM) procedure in Hispanic substance abusing outpatients. Thirty individuals meeting DSM-IV criteria for substance dependence receive one of two conditions: (a) standard treatment, or (b) standard treatment plus prize CM. Using a cross-over design, CM is implemented in a community-based outpatient clinic and compared with non-CM in the same clinic. The participating clinic is randomly assigned to receive either the CM or non-CM phase first; 15 weeks after the final participant in one phase is enrolled, a one-week washout period occurs, followed by a switch to the other phase. Patients initiating outpatient treatment during the non-CM phase receive standard treatment and submit urine and breath samples 2/week during Weeks 1-6 and 1/week during Weeks 7-12. Patients initiating treatment during the CM phase also receive standard treatment and the same breath and urine monitoring. In addition, they earn the opportunity to win prizes for coming to treatment and for submitting negative breath and urine samples. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.
- Conditions
- Substance Abuse
- Being tested
- Contingency management
- Keywords
- contingency management, substance abuse
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug 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 startAug 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- UConn Health
- Investigators
- Nancy Petry, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249548
- Sponsor's protocol ID
- NIDA-13444-3
- Other IDs
- R01-13444-3
- Status last verified
- May 2008
- First submitted
- 3 Nov 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Cost Contingency Management for Hispanic Outpatients
- ClinicalTrials.gov ID
- NCT00249548
- Acronym / sponsor ID
- NIDA-13444-3
- Conditions
- Substance Abuse
- Keywords
- contingency management, substance abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- UConn Health
- Study start
- Aug 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (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 evaluate the effectiveness of a lower-cost contingency management (CM) procedure in Hispanic substance abusing outpatients. Thirty individuals meeting DSM-IV criteria for substance dependence receive one of two conditions: (a) standard treatment, or (b) standard treatment plus prize CM. Using a cross-over design, CM is implemented in a community-based outpatient clinic and compared with non-CM in the same clinic. The participating clinic is randomly assigned to receive either the CM or non-CM phase first; 15 weeks after the final participant in one phase is enrolled, a one-week washout period occurs, followed by a switch to the other phase. Patients initiating outpatient treatment during the non-CM phase receive standard treatment and submit urine and breath samples 2/week during Weeks 1-6 and 1/week during Weeks 7-12. Patients initiating treatment during the CM phase also receive standard treatment and the same breath and urine monitoring. In addition, they earn the opportunity to win prizes for coming to treatment and for submitting negative breath and urine samples. 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- current DSM-IV substance dependence.
Key exclusion criteria (4 listed)
- have a 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
- have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975)
- DSM-IV diagnosis of pathological gambling
- plans to move from the Hartford are within 9 months.
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 management | Behavioural | – |
Primary outcome
Drug 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 12 Jan 2017.
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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 Petry, Ph.D. principal investigator
UConn Health
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management in people with Substance Abuse, run by National Institute on Drug Abuse (NIDA).
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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Drug 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 12 Jan 2017.