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

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Atomoxetine Hydrochloride; Cocaine; Methadone

Criteria

Inclusion Criteria:

• • Men and women between 18 and 65 years old.

• Current opioid dependence as evidenced by 1) documentation of prior treatment for opioid dependence or signs of withdrawal, 2) self-reported history of opioid dependence for 12 consecutive months and, 3) a positive urine toxicology screen for opiates.

• Diagnosis of opioid dependence and cocaine dependence by Diagnostic and Statisical Manual (DSM-IV) -criteria as well as laboratory confirmation of recent cocaine use in the form of positive urine toxicology during the month prior to study entry.

• For those who recently participated in a research study, at least 2 weeks of washout period before enrollment.

• A history of cocaine use,( a minimum of 1/2 gram during the preceding 30 days).

• Must be seeking treatment for opioid and cocaine use.

• For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.

Exclusion Criteria:

• • Serious medical illnesses including hypertension, tachycardia, bradycardia, or other arrhythmias and major cardiovascular, cerebrovascular, renal, endocrine, or hepatic disorders;

• Serious psychiatric illness, history of psychosis, schizophrenia or bipolar type I disorder.

• Current major depression. Subjects with current depressive symptoms not meeting criteria will be included in the study, with the exception of those endorsing suicidal and homicidal thoughts, will be excluded even if full criteria for major depression are not met.

• Current diagnosis of alcohol or drug dependence other than opiates, cocaine, nicotine and cannabis.

• Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.

• Has not been treated with monoamine oxidase inhibitors within the last fourteen days.

• Liver function tests (ALT or AST) greater than 3 times normal.

• Known allergy or intolerance to atomoxetine.