A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment
|ClinicalTrials.gov Identifier: NCT01802515|
Recruitment Status : Terminated (No funding stopped recruitment march 2014 with only 14 enrolled)
First Posted : March 1, 2013
Results First Posted : December 6, 2016
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence Opiate Dependence||Drug: Atomoxetine, low dose Drug: Atomoxetine, high dose Drug: Placebo||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Atomoxetine Treatment for Opioid Maintained Cocaine Users|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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.
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.
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
- Treatment Retention [ Time Frame: 8 weeks of treatment ]The number of participants completing all 8 weeks of treatment phase.
- Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale [ Time Frame: 8 weeks of treatment ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802515
|United States, Connecticut|
|Department of Veterans Affairs Hospital|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Mehmet Sofuoglu, M.D,Ph.D.||Yale University|