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
|Condition or disease||Intervention/treatment||Phase|
|Marijuana Abuse Attention Deficit Disorder With Hyperactivity||Drug: Atomoxetine Procedure: Motivational enhancement therapy Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Atomoxetine Treatment for ADHD and Marijuana Dependence|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Atomoxetine plus Motivational Enhancement Therapy
25 to 100 mg daily
Other Name: StratteraProcedure: Motivational enhancement therapy
Other Name: MET
Placebo Comparator: Placebo
Placebo plus Motivational Enhancement Therapy
Procedure: Motivational enhancement therapy
Other Name: METDrug: Placebo
25 to 100 mg daily
Other Name: Sugar pill
- Estimated Week 12 Self-reported Use [ Time Frame: One week (study week 12) ]Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back.
- Self-reported Longitudinal Use [ Time Frame: 12 weeks ]Participants' self-report of mean frequency of use of marijuana from baseline through week 12 visit of the study was assessed using a Time-Line Follow-Back.
- Urine Drug Screens [ Time Frame: 12 weeks ]Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.
- Wender-Reimherr Adult Attention Deficit Disorder Scale [ Time Frame: Baseline and Week 12 ]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).
- Clinical Global Impression, Improvement Scale [ Time Frame: 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360269
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Aimee L McRae, PharmD||Medical University of South Carolina|