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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

Tracking Information
First Submitted Date  ICMJE February 24, 2016
First Posted Date  ICMJE March 7, 2016
Last Update Posted Date June 25, 2018
Study Start Date  ICMJE February 2016
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Number of Cocaine Positive Urines [ Time Frame: Six weeks ]
Cocaine use will be assessed using qualitative urine drug screens over a six week period.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
Number of Choices to Earn Cocaine [ Time Frame: Following at least four days of maintenance on placebo or target duloxetine, methylphenidate or combined duloxetine-methylphenidate doses. ]
The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects can earn previously sampled doses.
Change History Complete list of historical versions of study NCT02700711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • 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.
  • Blood Pressure [ Time Frame: Six weeks ]
    Blood Pressure in mmHG will be measured on each week day over a six week period.
  • Heart Rate [ Time Frame: Six weeks ]
    Heart Rate in beats per minute will be measured on each week day over a six week period.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
  • Visual Analog Scale of Drug Effects [ Time Frame: Following at least four days of maintenance on placebo or target duloxetine, methylphenidate or combined duloxetine-methylphenidate doses. ]
    Subjects will report drug effects of cocaine combined with the maintenance doses. Peak effect (i.e., the maximum effect observed following administration of cocaine) will be calculated for each cocaine and maintenance dose condition. Reports will be captured on a visual analog scale of 0-100 units.
  • Stimulant Adjective Rating Scale [ Time Frame: Following at least four days of maintenance on placebo or target duloxetine, methylphenidate or combined duloxetine-methylphenidate doses. ]
    Subjects will report stimulant effects of cocaine combined with the maintenance doses on the Stimulant Adjective Rating Scale. Peak effect (i.e., the maximum effect observed following administration of cocaine) will be calculated for each cocaine and maintenance dose condition. Subjects will rate 16 items on a 0-4 Likert Scale that will then be summed to arrive at a global stimulant score.
  • Sedative Adjective Rating Scale [ Time Frame: Following at least four days of maintenance on placebo or target duloxetine, methylphenidate or combined duloxetine-methylphenidate doses. ]
    Subjects will report sedative effects on the Sedative Adjective Rating Scale. Peak effect (i.e., the maximum effect observed following administration of cocaine) will be calculated for each cocaine and maintenance dose condition. Subjects will rate 16 items on a 0-4 Likert Scale that will then be summed to arrive at a global sedative score.
  • Blood Pressure [ Time Frame: Daily over approximately three week inpatient admission ]
    Blood Pressure in mmHG will be completed daily while subjects are admitted to our inpatient unit. Data will be averaged over days as a function of cocaine and maintenance dose conditions.
  • Heart Rate [ Time Frame: Daily over approximately three week inpatient admission ]
    Heart Rate in beats per minute will be completed daily while subjects are admitted to our inpatient unit. Data will be averaged over days as a function of cocaine and maintenance dose conditions.
  • Temperature [ Time Frame: Daily over approximately three week inpatient admission ]
    Temperature in degrees fahrenheit will be completed daily while subjects are admitted to our inpatient unit. Data will be averaged over days as a function of cocaine and maintenance dose conditions.
  • Side effects [ Time Frame: Daily over approximately three week inpatient admission ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methylphenidate-Duloxetine Combinations for Cocaine Dependence
Official Title  ICMJE Randomized Clinical Trial: 03 (Methylphenidate and Duloxetine)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Cocaine Use Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance.
    Interventions:
    • Drug: Methylphenidate
    • Drug: Placebo
  • Experimental: Duloxetine
    Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.
    Interventions:
    • Drug: Methylphenidate
    • Drug: Placebo
    • Drug: Duloxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2018)
13
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2016)
16
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02700711
Other Study ID Numbers  ICMJE RCT: 03
R56DA041201 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will be shared per NIH policy. Individual participant data will not be shared.
Responsible Party Craig Rush, University of Kentucky
Study Sponsor  ICMJE University of Kentucky
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
PRS Account University of Kentucky
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP