MedTrace Logo

A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment

NCT01802515 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-12-06

Study results available
· View outcomes & findings →

Summary

The main goal of this study is to evaluate the safety and tolerability of 40 or 80 mg atomoxetine as a treatment for cocaine dependence. The Phase I studies summarized above support the safety of atomoxetine in combination with stimulants. As the next step, the investigators will evaluate the safety and tolerability of atomoxetine in a small clinical trial with cocaine users. If atomoxetine is found to be promising in this study and sufficiently powered, double-blind, placebo-controlled studies will be proposed.

Conditions

  • Cocaine Dependence
  • Opiate Dependence

Interventions

DRUG

Atomoxetine, low dose

The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.

DRUG

Atomoxetine, high dose

The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.

DRUG

Placebo

The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Mehmet Sofuoglu, M.D,Ph.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01802515 on ClinicalTrials.gov