- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01802515
A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment
Atomoxetine Treatment for Opioid Maintained Cocaine Users
Study Overview
Status
Conditions
Intervention / Treatment
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.
This study has been terminated as of march 2014 due to the lack of funding, only 14 were enrolled with 11 subject completers. (June 2016)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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West Haven, Connecticut, United States, 06516
- Department of Veterans Affairs Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.
Other Names:
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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
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The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.
Other Names:
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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.
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The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Retention
Time Frame: 8 weeks of treatment
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The number of participants completing all 8 weeks of treatment phase.
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8 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale
Time Frame: 8 weeks of treatment
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Center for Epidemiological Studies-Depression.
The CES-D is a 20-item self-report measure of depressive symptoms.
Each of the 20 items can yield a score from 0 to 3 for a maximum total CES-D score of 60.
Larger values represent more severe symptoms.
It is a validated instrument with a score of 16 or more indicating clinically significant depression.
The CES-D change score was computed as (total baseline CES-D score - total CES-D score at end of study).
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8 weeks of treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Atomoxetine Hydrochloride
Other Study ID Numbers
- 1206010407
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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