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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT01802515
First received: February 27, 2013
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cocaine Dependence
Opiate Dependence
Drug: Atomoxetine, low dose
Drug: Atomoxetine, high dose
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Atomoxetine Treatment for Opioid Maintained Cocaine Users

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Proportion retained in treatment [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Cumulative probability of an individual's retention in 9 weeks of treatment will be compared between the treatment groups.


Enrollment: 14
Study Start Date: December 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atomoxetine, low dose
1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.
Drug: Atomoxetine, low dose
The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.
Other Names:
  • Strattera,
  • National Drug Codes - 00002-3229
Active Comparator: Atomoxetine, high dose
One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules
Drug: Atomoxetine, high dose
The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.
Other Name: Strattera, National Drug Codes - 00002-3250
Placebo Comparator: Placebo (sugar pill)
1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.
Drug: Placebo
The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.
Other Name: sugar pill

Detailed 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 completers. (June 2014)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802515

Locations
United States, Connecticut
Department of Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D,Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Mehmet Sofuoglu, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01802515     History of Changes
Other Study ID Numbers: 1206010407
Study First Received: February 27, 2013
Last Updated: June 13, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Yale University:
addiction
cocaine
methadone
opiates

Additional relevant MeSH terms:
Opioid-Related Disorders
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Methadone
Atomoxetine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid
Analgesics
Antitussive Agents
Respiratory System Agents
Narcotics
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on July 28, 2014