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

This study has been terminated.
(No funding stopped recruitment march 2014 with only 14 enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01802515
First Posted: March 1, 2013
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
Results First Submitted: July 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Cocaine Dependence
Opiate Dependence
Interventions: Drug: Atomoxetine, low dose
Drug: Atomoxetine, high dose
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult male and female participants were recruited from the Greater New Haven area from September 2012 to January 2014 by word-of-mouth, flyers and from referrals from treatment centers in the local area. The study was conducted in an outpatient clinic of the West Haven VA Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After eligibility was determined, participants were randomized to placebo, 40 mg atomoxetine or 80 mg atomoxetine. The study consisted of 3 phases 1) a two-week methadone induction phase 2) an 8-week treatment phase and 3) a 4-week taper and detoxification or transfer phase.

Reporting Groups
  Description
Atomoxetine, Low Dose

1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.

Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.

Atomoxetine, High Dose

One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules

Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.

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.

Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.


Participant Flow:   Overall Study
    Atomoxetine, Low Dose   Atomoxetine, High Dose   Placebo (Sugar Pill)
STARTED   5   5   4 
COMPLETED   2   5   4 
NOT COMPLETED   3   0   0 
Withdrawal by Subject                3                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atomoxetine, Low Dose

1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.

Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.

Atomoxetine, High Dose

One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules

Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.

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.

Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.

Total Total of all reporting groups

Baseline Measures
   Atomoxetine, Low Dose   Atomoxetine, High Dose   Placebo (Sugar Pill)   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   4   14 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.2  (8.0)   47.6  (5.63)   43.6  (0.95)   42.3  (7.4) 
Gender 
[Units: Participants]
       
Female   4   2   1   7 
Male   1   3   3   7 
Region of Enrollment 
[Units: Participants]
       
United States   5   5   4   14 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Retention   [ Time Frame: 8 weeks of treatment ]

2.  Secondary:   Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale   [ Time Frame: 8 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated after 14 subjects enrolled. 11 completers. 3 subjects dropped out in treatment week 7. There were no serious adverse events. Only descriptive statistics were computed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Mehmet Sofuoglu, Principal Investigator
Organization: Yale University
phone: 203 937-4809
e-mail: mehmet.sofuoglu@yale.edu



Responsible Party: Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier: NCT01802515     History of Changes
Other Study ID Numbers: 1206010407
First Submitted: February 27, 2013
First Posted: March 1, 2013
Results First Submitted: July 7, 2016
Results First Posted: December 6, 2016
Last Update Posted: December 6, 2016