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Behavioral Effects of Drugs: Inpatient (35) (BED IN 35)

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ClinicalTrials.gov Identifier: NCT03519022
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Craig Rush, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment Phase
Cocaine Use Disorder Drug: Cocaine Drug: Placebo oral capsule Drug: Methylphenidate Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Methylphenidate and Duloxetine Maintenance on Pharmacodynamic Effects of Cocaine
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019


Arm Intervention/treatment
Placebo Comparator: Placebo
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.
Drug: Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.

Drug: Placebo oral capsule
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.

Drug: Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Other Name: Metadate®

Active Comparator: Duloxetine
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.
Drug: Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.

Drug: Placebo oral capsule
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.

Drug: Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Other Name: Metadate®




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Adjective Rating Scale-Sedative [ Time Frame: Nine times over approximately four weeks inpatient admission. ]
    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.

  2. Adjective Rating Scale-Stimulant [ Time Frame: Nine times over approximately four weeks inpatient admission. ]
    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.

  3. Drug Effect Questionnaire [ Time Frame: Nine times over approximately four weeks inpatient admission. ]
    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.

  4. Heart rate [ Time Frame: Daily over approximately four week inpatient admissions. ]
    Beats per minute. Measured daily during inpatient admission.

  5. Blood pressure [ Time Frame: Daily over approximately four week inpatient admissions. ]
    mmHg.Measured daily during inpatient admission.

  6. Temperature [ Time Frame: Daily over approximately four week inpatient admissions. ]
    Degrees fahrenheit. Measured daily during inpatient admission.

  7. Side effects [ Time Frame: Daily over approximately four week inpatient admissions. ]
    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.

  8. Delay Discounting Task [ Time Frame: Nine times over approximately four weeks inpatient admission. ]
    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).

  9. Attentional Bias [ Time Frame: Nine times over approximately four weeks inpatient admission. ]
    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.

  10. Inhibitory Control [ Time Frame: Nine times over approximately four weeks inpatient admission. ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recent cocaine use

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519022


Locations
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United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536-0086
Sponsors and Collaborators
Craig Rush
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Craig R Rush, PhD University of Kentucky

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Responsible Party: Craig Rush, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03519022     History of Changes
Other Study ID Numbers: 43500
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Methylphenidate
Cocaine
Duloxetine Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics
Antidepressive Agents
Psychotropic Drugs