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Methylphenidate-Duloxetine Combinations for Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT02700711
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : June 25, 2018
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 (e.g., Ritalin®) and duloxetine (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and urine drug screens.

Condition or disease Intervention/treatment Phase
Cocaine Use Disorder Drug: Methylphenidate Drug: Placebo Drug: Duloxetine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine)
Study Start Date : February 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance.
Drug: Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Other Name: Ritalin

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

Experimental: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.
Drug: Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Other Name: Ritalin

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

Drug: Duloxetine
The pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate
Other Name: Cymbalta




Primary Outcome Measures :
  1. Number of Cocaine Positive Urines [ Time Frame: Six weeks ]
    Cocaine use will be assessed using qualitative urine drug screens over a six week period.


Secondary Outcome Measures :
  1. Self-Reported Cocaine Use [ Time Frame: Six weeks ]
    Cocaine use will be assessed using self-report on the Time Line Follow Back over a six week period.

  2. Blood Pressure [ Time Frame: Six weeks ]
    Blood Pressure in mmHG will be measured on each week day over a six week period.

  3. Heart Rate [ Time Frame: Six weeks ]
    Heart Rate in beats per minute will be measured on each week day over a six week period.

  4. Side effects [ Time Frame: Six weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recent cocaine use
  • Seeking treatment for 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 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

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): NCT02700711


Locations
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United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
National Institute on Drug Abuse (NIDA)

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Responsible Party: Craig Rush, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02700711     History of Changes
Other Study ID Numbers: RCT: 03
R56DA041201 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared per NIH policy. Individual participant data will not be shared.
Additional relevant MeSH terms:
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Duloxetine Hydrochloride
Methylphenidate
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
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs