Methylphenidate-Duloxetine Combinations for Cocaine Dependence

NCT ID: NCT02700711

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Methylphenidate

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Duloxetine

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

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Duloxetine

Intervention Type DRUG

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

Interventions

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Methylphenidate

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Duloxetine

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

Intervention Type DRUG

Other Intervention Names

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Ritalin Cymbalta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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Craig Rush

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Kentucky Medical Center

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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R56DA041201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RCT: 03

Identifier Type: -

Identifier Source: org_study_id

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