Cocaine DependencePhase 2NCT01393457
Cognitive Remediation for Cocaine Dependence
A Phase 2 study testing levodopa/carbidopa, Ropinirole 2 mg/d and Ropinirole 4 mg/d in people with Cocaine Dependence, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- levodopa/carbidopa, Ropinirole 2 mg/d and Ropinirole 4 mg/d
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- meet criteria for cocaine dependence
- seeking treatment for cocaine dependence
- be in acceptable health based on medical history and physical exam
Who cannot join
- dependent on drugs other than cocaine, nicotine, marijuana
- have a medical condition contraindicating treatment with study medications
- having conditions of probation or parole requiring reports of drug use to officers of the court
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral and Biomedical Sciences Building
Houston, Texas, 77045
About this study
Official title: Cognitive-enhancing DA Medications for Cocaine Dependence
The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.
- Conditions
- Cocaine Dependence
- Being tested
- levodopa/carbidopa, Ropinirole 2 mg/d, Placebo, Ropinirole 4 mg/d
- Keywords
- cocaine, cognition, medication, 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.
levodopa/carbidopaDrug
Also called ldopa
800/200 mg/d
Ropinirole 2 mg/dDrug
Also called Requip
2 mg/d
PlaceboDrug
sugar pill
Ropinirole 4 mg/dDrug
Also called Requip
4 mg/d
| Study group | Role | What they receive |
|---|---|---|
| ldopa + ropinirole low dose | Active comparator | levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d Receives: Drug: levodopa/carbidopa; Drug: Ropinirole 2 mg/d |
| ldopa + ropinirole high dose | Active comparator | levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d Receives: Drug: levodopa/carbidopa; Drug: Ropinirole 4 mg/d |
| ldopa | Active comparator | levodopa/carbidopa 800/200 mg/d Receives: Drug: levodopa/carbidopa |
| placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Use Based on Urine Drug Screening
The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.
Measured: 10 weeks
Secondary outcomes (1)
Number of Participants Who Completed the 10 Week Trial
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy Schmitz, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393457
- Sponsor's protocol ID
- DA030787
- Status last verified
- Mar 2018
- First submitted
- 11 Jul 2011
- Last updated
- 29 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Suchting R, Green CE, de Dios C, Vincent J, Moeller FG, Lane SD, Schmitz JM. Citalopram for treatment of cocaine use disorder: A Bayesian drop-the-loser randomized clinical trial. Drug Alcohol Depend. 2021 Nov 1;228:109054. doi: 10.1016/j.drugalcdep.2021.109054. Epub 2021 Sep 23.
PubMed 34600245
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-enhancing DA Medications for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01393457
- Acronym / sponsor ID
- DA030787
- Conditions
- Cocaine Dependence
- Keywords
- cocaine, cognition, medication, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 29 Mar 2018
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 treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ldopa + ropinirole low dose | Active comparator | Drug: levodopa/carbidopa, Drug: Ropinirole 2 mg/dlevodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d |
| ldopa + ropinirole high dose | Active comparator | Drug: levodopa/carbidopa, Drug: Ropinirole 4 mg/dlevodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d |
| ldopa | Active comparator | Drug: levodopa/carbidopalevodopa/carbidopa 800/200 mg/d |
| placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- meet criteria for cocaine dependence
- seeking treatment for cocaine dependence
- be in acceptable health based on medical history and physical exam
Key exclusion criteria (3 listed)
- dependent on drugs other than cocaine, nicotine, marijuana
- have a medical condition contraindicating treatment with study medications
- having conditions of probation or parole requiring reports of drug use to officers of the court
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/carbidopaAlso: ldopa800/200 mg/d | Drug | ldopa, ldopa + ropinirole high dose, ldopa + ropinirole low dose |
| Ropinirole 2 mg/dAlso: Requip2 mg/d | Drug | ldopa + ropinirole low dose |
| Placebosugar pill | Drug | placebo |
| Ropinirole 4 mg/dAlso: Requip4 mg/d | Drug | ldopa + ropinirole high dose |
Primary outcome
Cocaine Use Based on Urine Drug Screening
Time frame: 10 weeks
The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.
1 secondary outcome
Number of Participants Who Completed the 10 Week Trial
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34600245Suchting R, Green CE, de Dios C, Vincent J, Moeller FG, Lane SD, Schmitz JM. Citalopram for treatment of cocaine use disorder: A Bayesian drop-the-loser randomized clinical trial. Drug Alcohol Depend. 2021 Nov 1;228:109054. doi: 10.1016/j.drugalcdep.2021.109054. Epub 2021 Sep 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Ropinirole 2 mg/d and Ropinirole 4 mg/d in people with Cocaine Dependence, 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 3 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 29 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Based on Urine Drug Screening (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01393457, which also lists 1 linked publication.
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 Mar 2018.