Behavioral Effects of Drugs: Inpatient (35)

Early Phase 1CompletedNCT03519022

Craig Rush9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Cocaine Use Disorder

Interventions

CocaineDRUG

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.

Placebo oral capsuleDRUG

The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.

MethylphenidateDRUG

The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Kentucky Medical Center

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Reinforcing Effects of Cocaine Following Placebo Maintenance.

Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

Time frame: Following at least 4 days of maintenance on placebo during inpatient admission.

Reinforcing Effects of Cocaine Following Duloxetine Maintenance.

Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

Time frame: Following at least 4 days of maintenance on duloxetine during inpatient admission.

Reinforcing Effects of Cocaine Following Methylphenidate Maintenance.

Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

Time frame: Following at least 4 days of maintenance on duloxetine during inpatient admission.

Reinforcing Effects of Cocaine Following Methylphenidate and Duloxetine Maintenance.

Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

Time frame: Following at least 4 days of maintenance on methylphenidate and duloxetine during inpatient admission.

Secondary Outcomes

Adjective Rating Scale-Sedative

Subjects will complete the adjective rating scale during nine sessions while they are admitted to our inpatient unit. Responses to 16 items are summed (total score=0-64; Higher values=more sedation) to calculate scores on a sedative subscale.

Time frame: Nine times over approximately four weeks inpatient admission.

Adjective Rating Scale-Stimulant

Subjects will complete the adjective rating scale during nine sessions while they are admitted to our inpatient unit. Responses to 16 items are summed (total score=0-64; Higher values=more stimulation) to calculate total scores on a stimulant subscale.

Data from ClinicalTrials.gov

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