Behavioral Effects of Drugs: Inpatient (35)

NCT03519022 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 43500
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Use Disorder

Outcome Measures

Primary Outcomes (4)

• Reinforcing Effects of Cocaine Following Placebo Maintenance.

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

  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.

  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.

  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.

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

Secondary Outcomes (10)

• Adjective Rating Scale-Sedative

  Nine times over approximately four weeks inpatient admission.

• Adjective Rating Scale-Stimulant

  Nine times over approximately four weeks inpatient admission.

• Drug Effect Questionnaire

  Nine times over approximately four weeks inpatient admission.

• Heart rate

  Daily over approximately four week inpatient admissions.

• Blood pressure

  Daily over approximately four week inpatient admissions.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

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

Duloxetine

ACTIVE COMPARATOR

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.

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

Interventions

Cocaine DRUG

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

Duloxetine; Placebo

Placebo oral capsule DRUG

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

Duloxetine; Placebo

Methylphenidate DRUG

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

Also known as: Metadate®

Duloxetine; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recent 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, 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

Sponsors & Collaborators

• Craig Rush: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0086, United States

Location

MeSH Terms

Interventions

Cocaine; Methylphenidate

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Craig R Rush, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 8, 2018
• Study Start: June 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 25, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)