Methylphenidate-Duloxetine Combinations for Cocaine Dependence

University of Kentucky

Status and phase: Completed; Phase 1

Conditions: Cocaine Use Disorder

Treatments: Drug: Duloxetine; Drug: Placebo; Drug: Methylphenidate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02700711

RCT: 03

R56DA041201 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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13 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance.

Treatment:

Drug: Methylphenidate

Drug: Placebo

Duloxetine

Experimental group

Description:

Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.

Treatment:

Drug: Methylphenidate

Drug: Placebo

Drug: Duloxetine