Cocaine Use DisorderPhase 1NCT02700711
Methylphenidate-Duloxetine Combinations for Cocaine Dependence
A Phase 1 study testing Methylphenidate and Duloxetine in people with Cocaine Use Disorder, run by University of Kentucky at 1 site in United States.
Trial summary
This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and urine drug screens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Methylphenidate and Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jun 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recent cocaine use
- Seeking treatment for cocaine use
Who cannot join
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease or current unstable physical disease (e.g., past myocardial infarction, uncontrolled hypertension, diabetes, head trauma, seizures or CNS tumors) or current or past histories of serious psychiatric disorder or suicidal risk, other than substance abuse or dependence, will be excluded from research participation
- Females not currently using effective birth control
- Contraindications to cocaine, methylphenidate or duloxetine
- Currently using opioids for pain or who are currently maintained on methadone or buprenorphine for opioid use disorder will be excluded from participation
- Body weight less than 50 kg
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
Official title: Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine)
This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and urine drug screens.
- Conditions
- Cocaine Use Disorder
- Being tested
- Methylphenidate, Placebo, Duloxetine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
PlaceboDrug
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
DuloxetineDrug
Also called Cymbalta
The pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Receives: Drug: Methylphenidate; Drug: Placebo |
| Duloxetine | Experimental | Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance. Receives: Drug: Methylphenidate; Drug: Placebo; Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cocaine Positive Urines
Cocaine use will be assessed using qualitative urine drug screens over a six week period.
Measured: Six weeks
Secondary outcomes (4)
Self-Reported Cocaine Use
Cocaine use will be assessed using self-report on the Time Line Follow Back over a six week period.
Measured: Six weeks
Blood Pressure
Blood Pressure in mmHG will be measured on each week day over a six week period.
Measured: Six weeks
Heart Rate
Heart Rate in beats per minute will be measured on each week day over a six week period.
Measured: Six weeks
Side effects
Subjects will complete a side effects questionnaire on each week day over a six week period. Side Effects questions will query subjects about common effects of centrally active medications.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Craig Rush, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700711
- Sponsor's protocol ID
- RCT: 03
- Other IDs
- R56DA041201
- Status last verified
- Jun 2018
- First submitted
- 24 Feb 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be shared per NIH policy. Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine)
- ClinicalTrials.gov ID
- NCT02700711
- Acronym / sponsor ID
- RCT: 03
- Conditions
- Cocaine Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 7 Mar 2016 (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.
This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and urine drug screens.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Methylphenidate, Drug: PlaceboSubjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. |
| Duloxetine | Experimental | Drug: Methylphenidate, Drug: Placebo, Drug: DuloxetineSubjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recent cocaine use
- Seeking treatment for cocaine use
Key exclusion criteria (7 listed)
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease or current unstable physical disease (e.g., past myocardial infarction, uncontrolled hypertension, diabetes, head trauma, seizures or CNS tumors) or current or past histories of serious psychiatric disorder or suicidal risk, other than substance abuse or dependence, will be excluded from research participation
- Females not currently using effective birth control
- Contraindications to cocaine, methylphenidate or duloxetine
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 |
|---|---|---|
| MethylphenidateAlso: RitalinThe pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine. | Drug | Duloxetine, Placebo |
| PlaceboThe pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine. | Drug | Duloxetine, Placebo |
| DuloxetineAlso: CymbaltaThe pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate | Drug | Duloxetine |
Primary outcome
Number of Cocaine Positive Urines
Time frame: Six weeks
Cocaine use will be assessed using qualitative urine drug screens over a six week period.
4 secondary outcomes
Self-Reported Cocaine Use
Time frame: Six weeks
Blood Pressure
Time frame: Six weeks
Heart Rate
Time frame: Six weeks
Side effects
Time frame: Six weeks
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 26 Jun 2018.
- Individual participant dataSharing planned: No. Data will be shared per NIH policy. Individual participant data will not be shared.
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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 Methylphenidate and Duloxetine in people with Cocaine Use Disorder, run by University of Kentucky 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 2 inclusion and 7 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 26 Jun 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 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?
Number of Cocaine Positive Urines (time frame: Six weeks). 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 26 Jun 2018.