Cocaine Use DisorderEarly Phase 1BED IN 35NCT03519022
Behavioral Effects of Drugs: Inpatient (35)
A Early Phase 1 study testing Cocaine and Methylphenidate in people with Cocaine Use Disorder, run by Craig Rush at 1 site in United States.
Trial summary
This study will determine the influence of methylphenidate (Metadate®) and duloxetine (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Cocaine and Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 May 2019
- Phase
- Early 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recent 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, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to cocaine, methylphenidate or duloxetine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0086
About this study
Official title: Influence of Methylphenidate and Duloxetine Maintenance on Pharmacodynamic Effects of Cocaine
This study will determine the influence of methylphenidate (Metadate®) and duloxetine (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.
- Conditions
- Cocaine Use Disorder
- Being tested
- Cocaine, Placebo oral capsule, Methylphenidate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocaineDrug
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.
Placebo oral capsuleDrug
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
MethylphenidateDrug
Also called Metadate®
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
| 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. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. Receives: Drug: Cocaine; Drug: Placebo oral capsule; Drug: Methylphenidate |
| Duloxetine | Active comparator | Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Cocaine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance. Receives: Drug: Cocaine; Drug: Placebo oral capsule; Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcing Effects of Cocaine Following Placebo Maintenance.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Measured: Following at least 4 days of maintenance on placebo during inpatient admission.
Reinforcing Effects of Cocaine Following Duloxetine Maintenance.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Measured: Following at least 4 days of maintenance on duloxetine during inpatient admission.
Reinforcing Effects of Cocaine Following Methylphenidate Maintenance.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Measured: Following at least 4 days of maintenance on duloxetine during inpatient admission.
Reinforcing Effects of Cocaine Following Methylphenidate and Duloxetine Maintenance.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Measured: Following at least 4 days of maintenance on methylphenidate and duloxetine during inpatient admission.
Secondary outcomes (10)
Adjective Rating Scale-Sedative
Subjects will complete the adjective rating scale during nine sessions while they are admitted to our inpatient unit. Responses to 16 items are summed (total score=0-64; Higher values=more sedation) to calculate scores on a sedative subscale.
Measured: Nine times over approximately four weeks inpatient admission.
Adjective Rating Scale-Stimulant
Subjects will complete the adjective rating scale during nine sessions while they are admitted to our inpatient unit. Responses to 16 items are summed (total score=0-64; Higher values=more stimulation) to calculate total scores on a stimulant subscale.
Measured: Nine times over approximately four weeks inpatient admission.
Drug Effect Questionnaire
Subjects will complete the drug effect questionnaire during nine sessions while they are admitted to our inpatient unit. The items (total scores=0-100; Higher scores=greater drug effect) on this scale categorize the constellation of drug effects endorsed by subjects.
Measured: Nine times over approximately four weeks inpatient admission.
Heart rate
Beats per minute. Measured daily during inpatient admission.
Measured: Daily over approximately four week inpatient admissions.
Blood pressure
mmHg.Measured daily during inpatient admission.
Measured: Daily over approximately four week inpatient admissions.
Temperature
Degrees fahrenheit. Measured daily during inpatient admission.
Measured: Daily over approximately four week inpatient admissions.
Side effects
Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.
Measured: Daily over approximately four week inpatient admissions.
Delay Discounting Task
Subjects will complete the delay discounting task during nine sessions while they are admitted to our inpatient unit. Responses will be used to calculate discounting slope (i.e., K).
Measured: Nine times over approximately four weeks inpatient admission.
Attentional Bias
Subjects will complete attentional bias during nine sessions while they are admitted to our inpatient unit. Time attending to drug stimuli will be used to evaluate attentional bias.
Measured: Nine times over approximately four weeks inpatient admission.
Inhibitory Control
Subjects will complete an inhibitory control task during nine sessions while they are admitted to our inpatient unit. Ability to inhibit prepotent responding will be used to calculate inhibitory control.
Measured: Nine times over approximately four weeks inpatient admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start1 Jun 2018
- Primary completion31 May 2019
- Study completion31 May 2019
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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Rush
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Craig Rush, University of Kentucky
- Investigators
- Craig R Rush, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519022
- Sponsor's protocol ID
- 43500
- Acronym
- BED IN 35
- Status last verified
- Jul 2018
- First submitted
- 11 Apr 2018
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Methylphenidate and Duloxetine Maintenance on Pharmacodynamic Effects of Cocaine
- ClinicalTrials.gov ID
- NCT03519022
- Acronym / sponsor ID
- BED IN 35 / 43500
- Conditions
- Cocaine Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Craig RushUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 8 May 2018 (actual)
- 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 (Metadate®) and duloxetine (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Cocaine, Drug: Placebo oral capsule, Drug: MethylphenidateSubjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
| Duloxetine | Active comparator | Drug: Cocaine, Drug: Placebo oral capsule, Drug: MethylphenidateSubjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Cocaine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recent cocaine use
Key exclusion criteria (5 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, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from 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 |
|---|---|---|
| CocaineThe pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine. | Drug | Duloxetine, Placebo |
| Placebo oral capsuleThe pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine. | Drug | Duloxetine, Placebo |
| MethylphenidateAlso: Metadate®The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine. | Drug | Duloxetine, Placebo |
Primary outcome
Reinforcing Effects of Cocaine Following Placebo Maintenance.
Time frame: Following at least 4 days of maintenance on placebo during inpatient admission.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Reinforcing Effects of Cocaine Following Duloxetine Maintenance.
Time frame: Following at least 4 days of maintenance on duloxetine during inpatient admission.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Reinforcing Effects of Cocaine Following Methylphenidate Maintenance.
Time frame: Following at least 4 days of maintenance on duloxetine during inpatient admission.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
Reinforcing Effects of Cocaine Following Methylphenidate and Duloxetine Maintenance.
Time frame: Following at least 4 days of maintenance on methylphenidate and duloxetine during inpatient admission.
Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.
10 secondary outcomes
Adjective Rating Scale-Sedative
Time frame: Nine times over approximately four weeks inpatient admission.
Adjective Rating Scale-Stimulant
Time frame: Nine times over approximately four weeks inpatient admission.
Drug Effect Questionnaire
Time frame: Nine times over approximately four weeks inpatient admission.
Heart rate
Time frame: Daily over approximately four week inpatient admissions.
Blood pressure
Time frame: Daily over approximately four week inpatient admissions.
Temperature
Time frame: Daily over approximately four week inpatient admissions.
Side effects
Time frame: Daily over approximately four week inpatient admissions.
Delay Discounting Task
Time frame: Nine times over approximately four weeks inpatient admission.
Attentional Bias
Time frame: Nine times over approximately four weeks inpatient admission.
Inhibitory Control
Time frame: Nine times over approximately four weeks inpatient admission.
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 25 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Craig R Rush, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cocaine and Methylphenidate in people with Cocaine Use Disorder, run by Craig Rush 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 1 inclusion and 5 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 25 Jun 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Reinforcing Effects of Cocaine Following Placebo Maintenance. (time frame: Following at least 4 days of maintenance on placebo during inpatient admission.). The study lists 4 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 25 Jun 2019.