Methylphenidate-Duloxetine Combinations for Cocaine Dependence

Phase 1

Completed

• Conditions: Cocaine Use Disorder
• Interventions: Drug: Methylphenidate; Drug: Placebo; Drug: Duloxetine

• Registration Number: NCT02700711
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-07
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance.
Duloxetine	Placebo	Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.
Duloxetine	Duloxetine	Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.
Placebo	Methylphenidate	Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance.
Duloxetine	Methylphenidate	Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.

Primary Outcome Measures

Name	Time	Method
Number of Cocaine Positive Urines	Six weeks	Cocaine use will be assessed using qualitative urine drug screens over a six week period.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States