Behavioral Effects of Drugs: Inpatient (35) (BED IN 35)

Craig Rush

Status and phase: Completed; Early Phase 1

Conditions: Cocaine Use Disorder

Treatments: Drug: Methylphenidate; Drug: Cocaine; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03519022

43500

Details and patient eligibility

About

This study will determine the influence of methylphenidate (Metadate®) and duloxetine (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.

Enrollment: 9 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Recent 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, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
• Females not currently using effective birth control
• Contraindications to cocaine, methylphenidate or duloxetine

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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9 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. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Treatment:

Drug: Placebo oral capsule

Drug: Cocaine

Drug: Methylphenidate

Duloxetine

Active Comparator group

Description:

Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Cocaine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.

Treatment:

Drug: Placebo oral capsule

Drug: Cocaine

Drug: Methylphenidate