The aim of the study is to determine if atomoxetine treatment combined with motivational enhancement therapy is effective in reducing marijuana use in adult individuals with attention-deficit hyperactivity disorder and marijuana dependence.
The purpose of this study is to determine whether the medication atomoxetine, or Strattera, plus 3 sessions of counseling can help people to reduce the symptoms of ADHD and to help cut back on their marijuana use. Participation in the study is approximately 12 weeks of medication treatment and doctor's visits once a week. The first 2 visits consist of evaluations to determine if you qualify to participate. These visits are approximately 2-3 hours long and will include questions about your past and present substance use, psychiatric history, a routine physical exam, bloodwork, and paper and pencil questionnaires about your marijuana use. Once you are enrolled in the study, visits are typically 30 minutes long, once a week. The one-on-one counseling sessions regarding marijuana use are 1 hour long and you will have 3 sessions throughout the study. If you qualify for this study, you will receive either atomoxetine, or a placebo (sugar pill). Study participants will have a 50% chance of receiving atomoxetine. Atomoxetine is a non-stimulant, commonly used to treat ADHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
25 to 100 mg daily
Three sessions
25 to 100 mg daily
Medical University of South Carolina
Charleston, South Carolina, United States
Estimated Week 12 Self-reported Use
Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back.
Time frame: One week (study week 12)
Self-reported Longitudinal Use
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.
Time frame: 12 weeks
Urine Drug Screens
Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.
Time frame: 12 weeks
Wender-Reimherr Adult Attention Deficit Disorder Scale
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
Clinical Global Impression, Improvement Scale
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
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