Methylphenidate-Duloxetine Combinations for Cocaine Dependence

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.

Study Overview

• Status: Completed
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Drug: Methylphenidate; Drug: Placebo; Drug: Duloxetine

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Cocaine Positive Urines	Cocaine use will be assessed using qualitative urine drug screens over a six week period.	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Cocaine Use	Cocaine use will be assessed using self-report on the Time Line Follow Back over a six week period.	Six weeks
Blood Pressure	Blood Pressure in mmHG will be measured on each week day over a six week period.	Six weeks
Heart Rate	Heart Rate in beats per minute will be measured on each week day over a six week period.	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.	Six weeks

Collaborators and Investigators

• Sponsor: University of Kentucky
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Duloxetine Hydrochloride; Methylphenidate
• Other Study ID Numbers: RCT: 03; R56DA041201 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be shared per NIH policy. Individual participant data will not be shared.