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Atomoxetine Treatment for ADHD and Marijuana Dependence

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ClinicalTrials.gov Identifier: NCT00360269
Recruitment Status : Completed
First Posted : August 4, 2006
Results First Posted : April 9, 2012
Last Update Posted : December 30, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Marijuana Abuse
Attention Deficit Disorder With Hyperactivity
Interventions Drug: Atomoxetine
Procedure: Motivational enhancement therapy
Drug: Placebo
Enrollment 38
Recruitment Details Participants recruited between November 2005 and June 2008 primarily through media advertisements and fliers
Pre-assignment Details  
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description Flexible dose up to 100mg/day Flexible dose up to 100mg/day
Period Title: Overall Study
Started 19 19
Completed 9 7
Not Completed 10 12
Reason Not Completed
Lost to Follow-up             7             9
Physician Decision             1             2
Adverse Event             1             0
Withdrawal by Subject             1             1
Arm/Group Title Atomoxetine Placebo Total
Hide Arm/Group Description Flexible dose up to 100mg/day Flexible dose up to 100mg/day Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
19
 100.0%
38
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
29.4  (10.0) 30.4  (13.0) 29.9  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
3
  15.8%
6
  31.6%
9
  23.7%
Male
16
  84.2%
13
  68.4%
29
  76.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
1.Primary Outcome
Title Estimated Week 12 Self-reported Use
Time Frame One week (study week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Flexible dose up to 100mg/day
Flexible dose up to 100mg/day
Overall Number of Participants Analyzed 19 19
Mean (Standard Error)
Unit of Measure: Times per day
2.17  (.34) 1.84  (.34)
2.Secondary Outcome
Title Self-reported Longitudinal Use
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Flexible dose up to 100mg/day
Flexible dose up to 100mg/day
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Percentage of days used
60.1  (31.5) 68.1  (31.3)
3.Secondary Outcome
Title Urine Drug Screens
Hide Description Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Flexible dose up to 100mg/day
Flexible dose up to 100mg/day
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: Percentage of positive UDS
87.3 85.3
4.Secondary Outcome
Title Wender-Reimherr Adult Attention Deficit Disorder Scale
Hide Description The WRAADDS is intended to measure the severity of ADHD symptoms in adults. It measures symptoms in seven categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional over-reactivity, disorganization, and impulsivity. The scale rates individual items from 0–2 (0=not present, 1=mild, 2=clearly present), with a minimum score of 0 and maximum score of 46. Reported here is change from Baseline to Week 12 (or LOCF).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Flexible dose up to 100mg/day
Flexible dose up to 100mg/day
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-15.05  (10.96) -11.05  (7.59)
5.Secondary Outcome
Title Clinical Global Impression, Improvement Scale
Hide Description The Clinical Global Impression - Improvement scale (CGI-I) was used to assess improvement in ADHD symptoms during study participation. CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Flexible dose up to 100mg/day
Flexible dose up to 100mg/day
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.63  (0.68) 3.26  (0.93)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description Flexible dose up to 100mg/day Flexible dose up to 100mg/day
All-Cause Mortality
Atomoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atomoxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   19/19 (100.00%)   16/19 (84.21%) 
Gastrointestinal disorders     
Gastrointestinal *  9/19 (47.37%)  4/19 (21.05%) 
General disorders     
Dry mouth *  3/19 (15.79%)  3/19 (15.79%) 
Hot/cold flashes *  3/19 (15.79%)  0/19 (0.00%) 
Insomnia *  0/19 (0.00%)  4/19 (21.05%) 
Sinus/allergies/flu-like symptoms *  7/19 (36.84%)  9/19 (47.37%) 
Other *  5/19 (26.32%)  3/19 (15.79%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal *  6/19 (31.58%)  5/19 (26.32%) 
Nervous system disorders     
Dizziness/lightheaded *  6/19 (31.58%)  3/19 (15.79%) 
Drowsiness *  3/19 (15.79%)  3/19 (15.79%) 
Headache *  7/19 (36.84%)  5/19 (26.32%) 
Psychiatric disorders     
Anxiety/depression *  3/19 (15.79%)  2/19 (10.53%) 
Irritability *  2/19 (10.53%)  1/19 (5.26%) 
Renal and urinary disorders     
Increased urination *  0/19 (0.00%)  2/19 (10.53%) 
Reproductive system and breast disorders     
Sexual dysfunction *  5/19 (26.32%)  0/19 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory *  0/19 (0.00%)  1/19 (5.26%) 
*
Indicates events were collected by non-systematic assessment
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: Aimee McRae-Clark, Pharm.D., BCPP
Organization: Medical University of South Carolina
Phone: 843-792-5215
Responsible Party: Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00360269     History of Changes
Obsolete Identifiers: NCT00227851
Other Study ID Numbers: R21DA018221 ( U.S. NIH Grant/Contract )
R21DA018221 ( U.S. NIH Grant/Contract )
First Submitted: August 2, 2006
First Posted: August 4, 2006
Results First Submitted: November 7, 2011
Results First Posted: April 9, 2012
Last Update Posted: December 30, 2014