Cocaine DependencePhase 1NCT01978431
Impulsivity and Stimulant Administration
A Phase 1 study testing cocaine hydrochloride and methylphenidate in people with Cocaine Dependence and Impulsivity, run by Yale University at 1 site in United States.
Trial summary
Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Dependence, Impulsivity
- What is being tested?
- cocaine hydrochloride and methylphenidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 2014
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 - 50 years,
- voluntary, written, informed consent,
- physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
- DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
- recent street cocaine use in excess of amounts to be administered in the current study,
- intravenous and/or smoked (crack/ freebase) use,
- positive urine toxicology screen for cocaine,
- for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.
Who cannot join
- Other drug dependence (except nicotine) as determined by urine toxicology or interview
- < 1 year of cocaine dependence,
- a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
- a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
- current use of psychotropic and/or potentially psychoactive prescription medication,
- seeking treatment for drug abuse/dependence (for experimental cocaine component),
- physical or laboratory (β-HCG) evidence of pregnancy.
- current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity.
- Conditions
- Cocaine Dependence, Impulsivity
- Being tested
- cocaine hydrochloride, methylphenidate
- Medical subject headings
- Cocaine-Related Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cocaine hydrochlorideDrug
methylphenidateDrug
| Study group | Role | What they receive |
|---|---|---|
| Stimulant | Experimental | Cocaine and Methylphenidate Receives: Drug: cocaine hydrochloride; Drug: methylphenidate |
| Placebo | Placebo comparator | methylphenidate Receives: Drug: methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cocaine inter-infusion interval
Subjects complete three separate 60 minute long "binge" cocaine self administration sessions (low dose 8mg/70kg, medium dose 16mg/70kg, and large dose 32mg/70kg). Mean inter-infusion intervals (time between cocaine boluses) are then averaged by adding all intervals within each session and dividing by 60. Intervals during which pump access is withheld (due to increase in vital signs) will be excluded. Data on cocaine self-administration (total number of responses, infusions, and III), subjective effects, and vital signs will be checked for normality prior to analysis using Kolmogorov-Smirnov statistics and normal probability plots. The significance level for all statistical tests will be set at p<.05.
Measured: 3 hours
Secondary outcomes (2)
Stop Signal Reaction Time (Impulsivity)
The Dependent measures pertinent to the effects of an acute/chronic exposure to stimulants (methylphenidate/cocaine) on measures of impulsivity will be analyzed using a mixed design ANOVA. This design will have a within subjects variable to study the effects of an acute exposure to stimulants (methylphenidate vs. placebo) and a between subjects variable to study the effects of a chronic exposure to stimulants (cocaine dependent subjects vs. healthy controls).
Measured: 5 years
Inter-Temporal Choice (Impulsivity)
The Dependent measures pertinent to the effects of an acute/chronic exposure to stimulants (methylphenidate/cocaine) on measures of impulsivity will be analyzed using a mixed design ANOVA. This design will have a within subjects variable to study the effects of an acute exposure to stimulants (methylphenidate vs. placebo) and a between subjects variable to study the effects of a chronic exposure to stimulants (cocaine dependent subjects vs. healthy controls).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Gustavo Angarita, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978431
- Sponsor's protocol ID
- 1001006250
- Other IDs
- R25MH071584
- Status last verified
- Feb 2023
- First submitted
- 17 Oct 2013
- Last updated
- 16 Feb 2023
- Results posted
- No
Publications
Kohler RJ, Zhornitsky S, Potenza MN, Yip SW, Worhunsky P, Angarita GA. Cocaine self-administration behavior is associated with subcortical and cortical morphometry measures in individuals with cocaine use disorder. Am J Drug Alcohol Abuse. 2024 May 3;50(3):345-356. doi: 10.1080/00952990.2024.2318585. Epub 2024 Mar 29.
PubMed 38551365
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulsivity and Stimulant Administration
- ClinicalTrials.gov ID
- NCT01978431
- Acronym / sponsor ID
- 1001006250
- Conditions
- Cocaine Dependence, Impulsivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2012 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Nov 2013 (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.
Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulant | Experimental | Drug: cocaine hydrochloride, Drug: methylphenidateCocaine and Methylphenidate |
| Placebo | Placebo comparator | Drug: methylphenidatemethylphenidate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- age 18 - 50 years,
- voluntary, written, informed consent,
- physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
- DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
- recent street cocaine use in excess of amounts to be administered in the current study,
Key exclusion criteria (8 listed)
- Other drug dependence (except nicotine) as determined by urine toxicology or interview
- < 1 year of cocaine dependence,
- a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
- a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
- current use of psychotropic and/or potentially psychoactive prescription medication,
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 |
|---|---|---|
| cocaine hydrochloride | Drug | Stimulant |
| methylphenidate | Drug | Placebo, Stimulant |
Primary outcome
Mean cocaine inter-infusion interval
Time frame: 3 hours
Subjects complete three separate 60 minute long "binge" cocaine self administration sessions (low dose 8mg/70kg, medium dose 16mg/70kg, and large dose 32mg/70kg). Mean inter-infusion intervals (time between cocaine boluses) are then averaged by adding all intervals within each session and dividing by 60. Intervals during which pump access is withheld (due to increase in vital signs) will be excluded. Data on cocaine self-administration (total number of responses, infusions, and III), subjective effects, and vital signs will be checked for normality prior to analysis using Kolmogorov-Smirnov statistics and normal probability plots. The significance level for all statistical tests will be set at p<.05.
2 secondary outcomes
Stop Signal Reaction Time (Impulsivity)
Time frame: 5 years
Inter-Temporal Choice (Impulsivity)
Time frame: 5 years
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 16 Feb 2023.
- Derived from this study: PubMed 38551365Kohler RJ, Zhornitsky S, Potenza MN, Yip SW, Worhunsky P, Angarita GA. Cocaine self-administration behavior is associated with subcortical and cortical morphometry measures in individuals with cocaine use disorder. Am J Drug Alcohol Abuse. 2024 May 3;50(3):345-356. doi: 10.1080/00952990.2024.2318585. Epub 2024 Mar 29.
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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 1 study testing cocaine hydrochloride and methylphenidate in people with Cocaine Dependence and Impulsivity, run by Yale University 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 8 inclusion and 8 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 16 Feb 2023. 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 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?
Mean cocaine inter-infusion interval (time frame: 3 hours). 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 NCT01978431, 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 16 Feb 2023.