Cocaine AbusePhase 1COSTNCT01437293
Behavioral and Physiological Effects of Cocaine in Cocaine-dependent Participants Treated With Levodopa in Combination With Carbidopa and Entacapone (LCE)
A Phase 1 study testing L-dopa / carbidopa / entacapone (LCE) in people with Cocaine Abuse, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
An inpatient safety study to characterize the cardiovascular and behavioral effects of cocaine administration in the presence of LCE. The proposed study involves an inpatient stay of 12 days during which participants will have two cocaine-administration sessions, each including five doses of smoked cocaine with… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Cocaine Abuse
- What is being tested?
- L-dopa / carbidopa / entacapone (LCE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Apr 2012
- Phase
- Phase 1
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult, age 21-50.
- Smokes cocaine on average at least 1x/week; currently spends at least $30/week on cocaine. Has been using cocaine for at least 6 months Urine toxicology positive for cocaine metabolites
- Has patterns of smoked cocaine use in terms of frequency and amount that parallels or exceed those administered in the study
- Able to give informed consent and comply with study procedures
Who cannot join
- Current DSM-IV criteria of substance use disorders with the exception of cocaine or nicotine dependence, or a history of alcohol or cannabis dependence.
- Request for drug treatment
- Unstable medical disorders, or medical disorders that might interfere with study participation, including current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
- Judged to be noncompliant with study protocol
- Concurrent use of any psychotropic medications
- Concurrent use of MAO inhibitors or epinephrine (patients must be off MAOIs for a minimum of 2 weeks)
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- Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (systolic BP > 140 and < 90, diastolic BP > 90 and < 60, and heart rate > 90; BUN, creatinine, LFTs > ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)
- Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
- History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
- History of narrow angle glaucoma or prostate cancer
- History of melanoma or current suspicious undiagnosed skin lesions
- Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
- History of allergic reaction or adverse reaction to study medications (levodopa/carbidopa/entacapone).
- Current parole or probation
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
An inpatient safety study to characterize the cardiovascular and behavioral effects of cocaine administration in the presence of LCE. The proposed study involves an inpatient stay of 12 days during which participants will have two cocaine-administration sessions, each including five doses of smoked cocaine with ascending doses.
Read the detailed description
Cocaine dependence remains a serious public health problem; however no clearly effective pharmacological treatments have been identified to date. We hypothesize that identification of subgroups of cocaine-dependent patients will help to develop targeted and more effective treatments. We hypothesize that individuals who have difficulties in achieving abstinence have a deficit in dopaminergic functioning and correcting this deficit using dopaminergic medication levodopa in combination with carbidopa and entacapone (LCE) to increase availability and uptake of levodopa to synthesize dopamine in the brain will result in clinical improvement. We were unable to locate any clinical reports that might provide data on the interaction between cocaine and LCE. Therefore, we would like to conduct an inpatient safety study to characterize the cardiovascular and behavioral effects of cocaine administration in the presence of LCE. The proposed study involves an inpatient stay of 12 days during which participants will have two cocaine-administration sessions, each including five doses of smoked cocaine with ascending doses. Participants will be maintained on placebo capsules prior to the first study session and on the LCE prior to the second session. Physiological (HR, BP, ECG) as well as behavioral (subjective effects) effects of cocaine will be monitored during cocaine-administration sessions. Serial blood samples will also follow cocaine administration to assess whether the pharmacokinetics of cocaine is altered during treatment with LCE. All participants will also undergo two cognitive testing sessions, one on placebo and one on LCE, employing a computerized battery (Quarters, Gambling task, Drug Stroop, Threat Responsivity task). There will be an optional functional MRI (fMRI) component that will investigate behavioral and neural indicators of reward responsivity, thought to reflect dopaminergic transmission. Participants choosing to undergo fMRI testing will complete two sessions, on the same days as the cognitive task sessions. Data obtained in the present study will be used to inform the large, controlled trial of LCE in treatment seeking cocaine-dependent individuals.
- Conditions
- Cocaine Abuse
- Being tested
- L-dopa / carbidopa / entacapone (LCE)
- Keywords
- cocaine
- 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.
L-dopa / carbidopa / entacapone (LCE)Drug
Also called L/C/E
For this trial we propose a target dosage of L-dopa / carbidopa / entacapone of 400 mg L-dopa / 100mg carbidopa / 200 mg entacapone, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | L-dopa / carbidopa / entacapone (LCE) Receives: Drug: L-dopa / carbidopa / entacapone (LCE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Maximum SBP, maximum DPB will be obtained at baseline, prior to the first session dose, and after each consecutive dose (0, 6, 12, 25, 50, 50 mg). Changes from baseline in blood pressure in the used by cocaine administration under placebo condition will be compared to those obtained during treatment with LCE using repeated measures ANOVA.
Measured: (baseline) prior to and after each of the 6 cocaine administrations at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose
heart rate
Heart rate will be obtained at baseline, prior to the first session dose, and after each consecutive dose (0, 6, 12, 25, 50, 50mg). Changes from baseline in heart rate in the used by cocaine administration under placebo condition will be compared to those obtained during treatment with LCE using repeated measures ANOVA.
Measured: (baseline) prior to and after each of the 6 cocaine administrations at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose
Secondary outcomes (2)
Composite (or Profile) of Pharmacokinetics
Cmax, Area Under Curve, Tmax
Measured: 18, 32, 46, 60, 74, 104 minutes post dose
subjective cocaine experience
- An assessment of the subjective cocaine experience with and without study medication using a standard battery of 100 mm visual analog scales (VAS) that will be administered pre-dosing and after each dose. Each VAS item will be summarized using AUC, mean and peak scores collected for all time points and analyzed using ANOVA with corrections for multiple comparisons.
Measured: Done at baseline and at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionApr 2012
- Study completionApr 2012
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.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Columbia University
- Responsible party
- Principal investigator, Adam Bisaga, National Institute on Drug Abuse (NIDA)
- Investigators
- Adam Bisaga, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437293
- Sponsor's protocol ID
- #6141 P50 DA 009236-16
- Other IDs
- P50DA009236, P50DA009236-16
- Acronym
- COST
- Status last verified
- May 2018
- First submitted
- 18 Nov 2010
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Physiological Effects of Cocaine in Cocaine-dependent Participants Treated With Levodopa in Combination With Carbidopa and Entacapone (LCE)
- ClinicalTrials.gov ID
- NCT01437293
- Acronym / sponsor ID
- COST / #6141 P50 DA 009236-16
- Conditions
- Cocaine Abuse
- Keywords
- cocaine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Columbia University
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Sep 2011 (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.
An inpatient safety study to characterize the cardiovascular and behavioral effects of cocaine administration in the presence of LCE. The proposed study involves an inpatient stay of 12 days during which participants will have two cocaine-administration sessions, each including five doses of smoked cocaine with ascending doses.
Detailed description
Cocaine dependence remains a serious public health problem; however no clearly effective pharmacological treatments have been identified to date. We hypothesize that identification of subgroups of cocaine-dependent patients will help to develop targeted and more effective treatments. We hypothesize that individuals who have difficulties in achieving abstinence have a deficit in dopaminergic functioning and correcting this deficit using dopaminergic medication levodopa in combination with carbidopa and entacapone (LCE) to increase availability and uptake of levodopa to synthesize dopamine in the brain will result in clinical improvement. We were unable to locate any clinical reports that might provide data on the interaction between cocaine and LCE. Therefore, we would like to conduct an inpatient safety study to characterize the cardiovascular and behavioral effects of cocaine administration in the presence of LCE. The proposed study involves an inpatient stay of 12 days during which participants will have two cocaine-administration sessions, each including five doses of smoked cocaine with ascending doses. Participants will be maintained on placebo capsules prior to the first study session and on the LCE prior to the second session. Physiological (HR, BP, ECG) as well as behavioral (subjective effects) effects of cocaine will be monitored during cocaine-administration sessions. Serial blood samples will also follow cocaine administration to assess whether the pharmacokinetics of cocaine is altered during treatment with LCE. All participants will also undergo two cognitive testing sessions, one on placebo and one on LCE, employing a computerized battery (Quarters, Gambling task, Drug Stroop, Threat Responsivity task). There will be an optional functional MRI (fMRI) component that will investigate behavioral and neural indicators of reward responsivity, thought to reflect dopaminergic transmission. Participants choosing to undergo fMRI testing will complete two sessions, on the same days as the cognitive task sessions. Data obtained in the present study will be used to inform the large, controlled trial of LCE in treatment seeking cocaine-dependent individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: L-dopa / carbidopa / entacapone (LCE)L-dopa / carbidopa / entacapone (LCE) |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult, age 21-50.
- Smokes cocaine on average at least 1x/week; currently spends at least $30/week on cocaine. Has been using cocaine for at least 6 months Urine toxicology positive for cocaine metabolites
- Has patterns of smoked cocaine use in terms of frequency and amount that parallels or exceed those administered in the study
- Able to give informed consent and comply with study procedures
Key exclusion criteria (14 listed)
- Current DSM-IV criteria of substance use disorders with the exception of cocaine or nicotine dependence, or a history of alcohol or cannabis dependence.
- Request for drug treatment
- Unstable medical disorders, or medical disorders that might interfere with study participation, including current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
- Judged to be noncompliant with study protocol
- Concurrent use of any psychotropic 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 |
|---|---|---|
| L-dopa / carbidopa / entacapone (LCE)Also: L/C/EFor this trial we propose a target dosage of L-dopa / carbidopa / entacapone of 400 mg L-dopa / 100mg carbidopa / 200 mg entacapone, twice daily. | Drug | Experimental |
Primary outcome
Blood pressure
Time frame: (baseline) prior to and after each of the 6 cocaine administrations at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose
Maximum SBP, maximum DPB will be obtained at baseline, prior to the first session dose, and after each consecutive dose (0, 6, 12, 25, 50, 50 mg). Changes from baseline in blood pressure in the used by cocaine administration under placebo condition will be compared to those obtained during treatment with LCE using repeated measures ANOVA.
heart rate
Time frame: (baseline) prior to and after each of the 6 cocaine administrations at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose
Heart rate will be obtained at baseline, prior to the first session dose, and after each consecutive dose (0, 6, 12, 25, 50, 50mg). Changes from baseline in heart rate in the used by cocaine administration under placebo condition will be compared to those obtained during treatment with LCE using repeated measures ANOVA.
2 secondary outcomes
Composite (or Profile) of Pharmacokinetics
Time frame: 18, 32, 46, 60, 74, 104 minutes post dose
subjective cocaine experience
Time frame: Done at baseline and at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose
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 21 May 2018.
- stars websiteLink 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.
Adam Bisaga, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-dopa / carbidopa / entacapone (LCE) in people with Cocaine Abuse, run by New York State Psychiatric Institute 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 14 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 21 May 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Blood pressure (time frame: (baseline) prior to and after each of the 6 cocaine administrations at 4, 18, 32, 46, 60, 74, 104 and 134 minutes after the first dose). The study lists 2 primary outcomes in all. 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 21 May 2018.