Cocaine-related DisordersNCT00877435
Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial
A study testing Cognitive behavioral therapy (CBT) in people with Cocaine-related Disorders, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
The purpose of this study is to determine whether prize-based contingency management (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment of of cocaine-dependent patients compared to CBT only. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine-related Disorders
- What is being tested?
- Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Sep 2008to Oct 2014
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- cocaine dependence, aged 18 or older, other dependences
Who cannot join
- severe somatic, brain, or psychiatric disease, attention deficit disorders with medication methylphenidate
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Universitäre Psychiatrischen Kliniken
Basel, 4025
Fondation Phenix
Geneva, 1221
About this study
The purpose of this study is to determine whether prize-based contingency management (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment of of cocaine-dependent patients compared to CBT only. Patients were randomized to prizeCM + CBT (experimental group) or to CBT (control group) an treated over 24 weeks. It is the first trial of this type in Europe.
- Conditions
- Cocaine-related Disorders
- Being tested
- Cognitive behavioral therapy (CBT)
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cognitive behavioral therapy (CBT) + prize-based contingency management (prizeCM) Receives: Behavioral: Cognitive behavioral therapy (CBT) |
| 2 | Active comparator | Cognitive behavioral therapy (CBT) Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention in treatment, cocaine abstinence
cocaine abstinence: at least 3 consecutive weeks of cocaine abstinence, the maximum number of weeks of continous abstinence and proportions of cocaine-free urine samples during the entire 24-week and at 6-month follow-up.
Measured: 24 weeks
Secondary outcomes (1)
patients' satisfaction with the therapy, clinical measures
patients' satisfaction with prize-based contingency management and with CBT
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-related DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvie Petitjean, University Hospital, Basel, Switzerland
- Investigators
- Sylvie A Petitjean, Dr. phil., Principal investigator, Psychiatric Hospital of the University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877435
- Sponsor's protocol ID
- SNF-105314-120675
- Status last verified
- Jan 2015
- First submitted
- 6 Apr 2009
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00877435
- Acronym / sponsor ID
- SNF-105314-120675
- Conditions
- Cocaine-related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Apr 2009 (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 determine whether prize-based contingency management (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment of of cocaine-dependent patients compared to CBT only. Patients were randomized to prizeCM + CBT (experimental group) or to CBT (control group) an treated over 24 weeks. It is the first trial of this type in Europe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive behavioral therapy (CBT)Cognitive behavioral therapy (CBT) + prize-based contingency management (prizeCM) |
| 2 | Active comparator | Behavioral: Cognitive behavioral therapy (CBT)Cognitive behavioral therapy (CBT) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- cocaine dependence, aged 18 or older, other dependences
Key exclusion criteria (1 listed)
- severe somatic, brain, or psychiatric disease, attention deficit disorders with medication methylphenidate
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 |
|---|---|---|
| Cognitive behavioral therapy (CBT) | Behavioural | 1, 2 |
Primary outcome
retention in treatment, cocaine abstinence
Time frame: 24 weeks
cocaine abstinence: at least 3 consecutive weeks of cocaine abstinence, the maximum number of weeks of continous abstinence and proportions of cocaine-free urine samples during the entire 24-week and at 6-month follow-up.
1 secondary outcome
patients' satisfaction with the therapy, clinical measures
Time frame: 24 weeks
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 29 Jan 2015.
- Psychiatric Hospital of the University of Basel - Addiction Research UnitLink provided by the sponsor.
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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.
Sylvie A Petitjean, Dr. phil. principal investigator
Psychiatric Hospital of the University of Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) in people with Cocaine-related Disorders, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 1 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 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
retention in treatment, cocaine abstinence (time frame: 24 weeks). 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 29 Jan 2015.