Cocaine DependencePhase 2NCT00167258
Effectiveness and Costs of Enhanced Cocaine Treatments
A Phase 2 study testing Voucher Reinforcement, Extra Counseling Services and Voucher Reinforcement + Extra Counseling Services in people with Cocaine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
The study will evaluate the effectiveness, economic benefits, and costs of voucher reinforcement for cocaine and alcohol abstinence, additional counseling services, and their combination in a sample of cocaine dependent patients receiving outpatient treatment as usual in a community clinic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Voucher Reinforcement, Extra Counseling Services and Voucher Reinforcement + Extra Counseling Services
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Feb 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Enrollment in an intensive outpatient program (IOP) for no more than 1 month
- Current DSM-IV diagnosis of cocaine dependence (month prior to IOP treatment)
- 18-65 years of age
- Ability to provide names of informants to help locate subject for follow-up
Who cannot join
- IV heroin use in last year
- Acute medical/psychiatric diagnosis that precludes outpatient treatment
- Inpatient treatment for 6 weeks or more prior to IOP treatment
- Incarceration for 6 months or more prior to IOP treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The study will evaluate the effectiveness, economic benefits, and costs of voucher reinforcement for cocaine and alcohol abstinence, additional counseling services, and their combination in a sample of cocaine dependent patients receiving outpatient treatment as usual in a community clinic.
- Conditions
- Cocaine Dependence
- Being tested
- Voucher Reinforcement, Extra Counseling Services, Voucher Reinforcement + Extra Counseling Services
- 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.
Voucher ReinforcementBehavioural
Extra Counseling ServicesBehavioural
Voucher Reinforcement + Extra Counseling ServicesBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study completionFeb 2007
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.
- More trials run by University of PennsylvaniaThe 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
- Factorial
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- James R McKay, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167258
- Sponsor's protocol ID
- 702110
- Status last verified
- Dec 2009
- First submitted
- 9 Sep 2005
- Last updated
- 15 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Costs of Enhanced Cocaine Treatments
- ClinicalTrials.gov ID
- NCT00167258
- Acronym / sponsor ID
- 702110
- Conditions
- Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study completion
- Feb 2007
- First posted
- 14 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.
The study will evaluate the effectiveness, economic benefits, and costs of voucher reinforcement for cocaine and alcohol abstinence, additional counseling services, and their combination in a sample of cocaine dependent patients receiving outpatient treatment as usual in a community clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrollment in an intensive outpatient program (IOP) for no more than 1 month
- Current DSM-IV diagnosis of cocaine dependence (month prior to IOP treatment)
- 18-65 years of age
- Ability to provide names of informants to help locate subject for follow-up
Key exclusion criteria (4 listed)
- IV heroin use in last year
- Acute medical/psychiatric diagnosis that precludes outpatient treatment
- Inpatient treatment for 6 weeks or more prior to IOP treatment
- Incarceration for 6 months or more prior to IOP treatment
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 |
|---|---|---|
| Voucher Reinforcement | Behavioural | – |
| Extra Counseling Services | Behavioural | – |
| Voucher Reinforcement + Extra Counseling Services | Behavioural | – |
Primary outcome
Not reported in the source record.
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 15 Dec 2009.
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.
James R McKay, PhD principal investigator
University of Pennsylvania
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 Voucher Reinforcement, Extra Counseling Services and Voucher Reinforcement + Extra Counseling Services in people with Cocaine Dependence, run by University of Pennsylvania 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 15 Dec 2009. 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.
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 15 Dec 2009.