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

Status Completed

Clinical Trial 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.

Clinical Trial Description

This will be an approximately 13 to 14 week double-blind, placebo-controlled clinical trial testing the safety and feasibility of atomoxetine (40 or 80 mg/day) treatment, compared to placebo, in methadone-stabilized stimulant users. The study will have 3 phases: 1) a one to two week- methadone-induction phase; 2) an 8-week "treatment" phase; and 3) 1 week atomoxetine taper and about a 4-week methadone "taper and detoxification or transfer" phase. Subjects will be randomized to three treatment arms: 40 mg (n=15) atomoxetine, or 80 mg (n=15) atomoxetine, or placebo (n=15). During the methadone induction phase, subjects will be stabilized on methadone. During induction onto methadone, participants will be administered increasing doses of methadone starting at 30 mg daily, and this dose will be increased for stabilization of opiate withdrawal symptoms from 40 mg up to 140 mg depending on individual need. Based on the clinic schedule between 1 to 2 weeks after methadone treatment is initiated , atomoxetine treatment will be started at 40 mg/day. For those assigned to 80 mg of atomoxetine, the dose will be titrated up to 80 mg/day on the second week of treatment phase. At the end of the treatment-phase, subjects will undergo detoxification from methadone over a 4-week period based on an individual's needs, and they will concurrently be tapered off atomoxetine. All participants will receive a weekly one-hour of individual psychotherapy (Cognitive Behavioral Therapy) with experienced clinicians specifically trained to deliver the therapy, and who will receive ongoing supervision.

Currently this study is in data analysis phase with 11 subject completers. (December 2014) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01802515
Study type	Interventional
Source	Yale University
Contact
Status	Completed
Phase	N/A
Start date	December 2012
Completion date	March 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04994821` - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study	Phase 2
Completed	`NCT01601743` - Exercise as a Behavioral Treatment for Cocaine Dependence	N/A
Completed	`NCT01402492` - Cocaine Use Reduction With Buprenorphine	Phase 2/Phase 3
Completed	`NCT01176591` - HBPL Study of the Impact of the NK1 Antagonist Aprepitant	Phase 2
Completed	`NCT00880997` - The Efficacy of Doxazosin for Cocaine Users	Phase 1
Completed	`NCT00566969` - Cocaine Withdrawal and Pharmacotherapy Response	N/A
Completed	`NCT00585520` - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues	Phase 1
Completed	`NCT00368290` - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior	Phase 2
Completed	`NCT00322309` - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects	Phase 2
Completed	`NCT00385801` - Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence	Phase 2
Completed	`NCT00167245` - Topiramate for Alcohol and Cocaine Dependence	Phase 2
Completed	`NCT00842517` - Long Term Maintenance of Drug Abstinence	Phase 1
Completed	`NCT04411914` - Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid	Phase 1
Active, not recruiting	`NCT03266939` - Rebalancing the Serotonergic System in Cocaine Dependence	Phase 1
Completed	`NCT02563769` - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study	Phase 1
Recruiting	`NCT06159387` - Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts	Phase 4
Terminated	`NCT02935101` - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants	Phase 2
Completed	`NCT02018263` - Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans	Phase 1
Withdrawn	`NCT01406522` - Tacrine Effects on Cocaine Self-Administration and Pharmacokinetics	Phase 2
Completed	`NCT01573273` - Oxytocin in Cocaine Dependence	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms