Methylphenidate-Duloxetine Combinations for Cocaine Dependence

NCT02700711 | Completed Phase 1 DMC

• 2 other identifiers: RCT: 03R56DA041201
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Cocaine Positive Urines

  Cocaine use will be assessed using qualitative urine drug screens over a six week period.

  Six weeks

Secondary Outcomes (4)

• Self-Reported Cocaine Use

  Six weeks

• Blood Pressure

  Six weeks

• Heart Rate

  Six weeks

• Side effects

  Six weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Methylphenidate; Drug: Placebo

Duloxetine

EXPERIMENTAL

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

Drug: Methylphenidate; Drug: Placebo; Drug: Duloxetine

Interventions

Methylphenidate DRUG

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

Also known as: Ritalin

Duloxetine; Placebo

Placebo DRUG

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

Duloxetine; Placebo

Duloxetine DRUG

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

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent cocaine use
• Seeking treatment for cocaine use

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Methylphenidate; Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 7, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)