Cocaine AbusePhase 2NCT00218075
Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of Cocaine Dependence
A Phase 2 study testing Levodopa, Carbidopa and Clinical Management in people with Cocaine Abuse and Cocaine-Related Disorders, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Abuse, Cocaine-Related Disorders
- What is being tested?
- Levodopa, Carbidopa and Clinical Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Oct 2007
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets DSM-IV criteria for current cocaine dependence
- Provides at least one positive urine test for cocaine during study screening
- Good general health, based on a physical exam, lab tests, and an electrocardiogram
- Reads and writes English at a sixth grade level
Who cannot join
- Current Axis I depressive, psychotic, or anxiety disorder
- Currently in jail
- Pregnant or breastfeeding
- Requires certain medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: Behavioral Strategies to Maximize the Efficacy of Pharmacotherapy for Cocaine Dependence: Relapse Prevention With Contingency Management Procedures
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. In addition, this study will examine the effects of incentive rewards for treatment compliance.
Read the detailed description
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United States. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Levodopa is a medication that is used alone or in combination with carbidopa to treat Parkinson's disease. The purpose of this study is to determine the possible interactions between behavioral interventions and carbidopa/levodopa in order to treat cocaine dependent individuals.
This study will last 12 weeks and will involve two phases. The first phase will include three therapy conditions: 1) clinical management only, 2) clinical management and relapse prevention therapy, and 3) clinical management, relapse prevention therapy, and contingency management. All of the conditions in the first phase will be evaluated incrementally under active and placebo conditions while participants receive carbidopa/levodopa.
The second phase of the study will examine the contingency management procedure applications. Each of the three contingency management procedure applications targets specific behaviors that, when reinforced, may interact with carbidopa/levodopa to produce clinical benefits. Participants will receive relapse prevention therapy combined with a contingency management procedure that targets clinic attendance, medication compliance, and cocaine abstinence. Study visits will occur weekly throughout the study. In addition, participants will complete a one-year follow-up visit.
- Conditions
- Cocaine Abuse, Cocaine-Related Disorders
- Being tested
- Levodopa, Carbidopa, Clinical Management, Relapse Prevention Therapy, Contingency Management
- Keywords
- Cocaine addiction, cocaine treatment
- 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.
LevodopaDrug
CarbidopaDrug
Clinical ManagementBehavioural
Relapse Prevention TherapyBehavioural
Contingency ManagementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine use
Secondary outcomes (3)
Medication compliance
treatment retention
severity of addiction-related problems
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2000
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AbuseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Texas
- Responsible party
- Principal investigator, Joy Schmitz, The University of Texas Health Science Center, Houston
- Investigators
- John Grabowski, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218075
- Sponsor's protocol ID
- NIDA-09262-9
- Other IDs
- P50DA009262, P50-09262-9, DPMC
- Status last verified
- Jan 2016
- First submitted
- 16 Sep 2005
- Last updated
- 5 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Strategies to Maximize the Efficacy of Pharmacotherapy for Cocaine Dependence: Relapse Prevention With Contingency Management Procedures
- ClinicalTrials.gov ID
- NCT00218075
- Acronym / sponsor ID
- NIDA-09262-9
- Conditions
- Cocaine Abuse, Cocaine-Related Disorders
- Keywords
- Cocaine addiction, cocaine treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Texas
- Study start
- Mar 2000
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Sep 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.
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. In addition, this study will examine the effects of incentive rewards for treatment compliance.
Detailed description
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United States. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Levodopa is a medication that is used alone or in combination with carbidopa to treat Parkinson's disease. The purpose of this study is to determine the possible interactions between behavioral interventions and carbidopa/levodopa in order to treat cocaine dependent individuals.
This study will last 12 weeks and will involve two phases. The first phase will include three therapy conditions: 1) clinical management only, 2) clinical management and relapse prevention therapy, and 3) clinical management, relapse prevention therapy, and contingency management. All of the conditions in the first phase will be evaluated incrementally under active and placebo conditions while participants receive carbidopa/levodopa.
The second phase of the study will examine the contingency management procedure applications. Each of the three contingency management procedure applications targets specific behaviors that, when reinforced, may interact with carbidopa/levodopa to produce clinical benefits. Participants will receive relapse prevention therapy combined with a contingency management procedure that targets clinic attendance, medication compliance, and cocaine abstinence. Study visits will occur weekly throughout the study. In addition, participants will complete a one-year follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets DSM-IV criteria for current cocaine dependence
- Provides at least one positive urine test for cocaine during study screening
- Good general health, based on a physical exam, lab tests, and an electrocardiogram
- Reads and writes English at a sixth grade level
Key exclusion criteria (4 listed)
- Current Axis I depressive, psychotic, or anxiety disorder
- Currently in jail
- Pregnant or breastfeeding
- Requires certain medications
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 |
|---|---|---|
| Levodopa | Drug | – |
| Carbidopa | Drug | – |
| Clinical Management | Behavioural | – |
| Relapse Prevention Therapy | Behavioural | – |
| Contingency Management | Behavioural | – |
Primary outcome
Cocaine use
3 secondary outcomes
Medication compliance
treatment retention
severity of addiction-related problems
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 5 Jan 2016.
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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.
John Grabowski, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levodopa, Carbidopa and Clinical Management in people with Cocaine Abuse and Cocaine-Related Disorders, run by The University of Texas Health Science Center, Houston 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 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 5 Jan 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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. 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 5 Jan 2016.