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

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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
Sponsor:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University

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
Enrollment 14
Recruitment Details 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 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.
Arm/Group Title Atomoxetine, Low Dose Atomoxetine, High Dose Placebo (Sugar Pill)
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 5 5 4
Completed 2 5 4
Not Completed 3 0 0
Reason Not Completed
Withdrawal by Subject             3             0             0
Arm/Group Title Atomoxetine, Low Dose Atomoxetine, High Dose Placebo (Sugar Pill) Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 5 5 4 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 4 participants 14 participants
36.2  (8.0) 47.6  (5.63) 43.6  (0.95) 42.3  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 4 participants 14 participants
Female
4
  80.0%
2
  40.0%
1
  25.0%
7
  50.0%
Male
1
  20.0%
3
  60.0%
3
  75.0%
7
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 4 participants 14 participants
5 5 4 14
1.Primary Outcome
Title Treatment Retention
Hide Description The number of participants completing all 8 weeks of treatment phase.
Time Frame 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.
Arm/Group Title Atomoxetine, Low Dose Atomoxetine, High Dose Placebo (Sugar Pill)
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 5 5 4
Measure Type: Number
Unit of Measure: participants
2 5 4
2.Secondary Outcome
Title Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale
Hide Description 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).
Time Frame 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.
Arm/Group Title Atomoxetine, Low Dose Atomoxetine, High Dose Placebo (Sugar Pill)
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 2 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.2  (5.2) -2.2  (9.1) -3.3  (11.2)
Time Frame Adverse events were collected once per week on all enrolled subjects for the 8 weeks of the treatment phase.
Adverse Event Reporting Description The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
 
Arm/Group Title Atomoxetine, Low Dose Atomoxetine, High Dose Placebo (Sugar Pill)
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Atomoxetine, Low Dose Atomoxetine, High Dose Placebo (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine, Low Dose Atomoxetine, High Dose Placebo (Sugar Pill)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atomoxetine, Low Dose Atomoxetine, High Dose Placebo (Sugar Pill)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      4/5 (80.00%)      1/4 (25.00%)    
Gastrointestinal disorders       
heartburn   0/5 (0.00%)  0 1/5 (20.00%)  8 0/4 (0.00%)  0
constipation   1/5 (20.00%)  3 2/5 (40.00%)  4 0/4 (0.00%)  0
Nervous system disorders       
insomnia   1/5 (20.00%)  3 0/5 (0.00%)  0 0/4 (0.00%)  0
dry mouth   1/5 (20.00%)  4 2/5 (40.00%)  10 0/4 (0.00%)  0
headache   0/5 (0.00%)  0 1/5 (20.00%)  8 1/4 (25.00%)  1
dizziness   0/5 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0
chills   0/5 (0.00%)  0 1/5 (20.00%)  3 0/4 (0.00%)  0
yawning   0/5 (0.00%)  0 1/5 (20.00%)  8 0/4 (0.00%)  0
agitation   1/5 (20.00%)  3 3/5 (60.00%)  6 0/4 (0.00%)  0
depression   0/5 (0.00%)  0 3/5 (60.00%)  9 1/4 (25.00%)  5
tiredness   0/5 (0.00%)  0 3/5 (60.00%)  6 1/4 (25.00%)  4
anxiety   1/5 (20.00%)  1 2/5 (40.00%)  5 0/4 (0.00%)  0
decreased libido   0/5 (0.00%)  0 1/5 (20.00%)  8 0/4 (0.00%)  0
increased perspiration   0/5 (0.00%)  0 2/5 (40.00%)  3 0/4 (0.00%)  0
decreased appetite   1/5 (20.00%)  1 1/5 (20.00%)  3 0/4 (0.00%)  0
nightmares   0/5 (0.00%)  0 1/5 (20.00%)  1 1/4 (25.00%)  2
numbness   1/5 (20.00%)  2 2/5 (40.00%)  2 0/4 (0.00%)  0
decreased concentration   0/5 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  2
drowsiness   0/5 (0.00%)  0 2/5 (40.00%)  10 1/4 (25.00%)  2
hallucinations   1/5 (20.00%)  2 0/5 (0.00%)  0 0/4 (0.00%)  0
tingling   0/5 (0.00%)  0 1/5 (20.00%)  3 0/4 (0.00%)  0
ataxia   0/5 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0
Reproductive system and breast disorders       
cramps   1/5 (20.00%)  8 0/5 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
shortness of breath   0/5 (0.00%)  0 2/5 (40.00%)  7 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
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.
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
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