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Phase 2 N=38 Randomized Double-blind Treatment

Atomoxetine Treatment for ADHD and Marijuana Dependence

Marijuana Abuse · Attention Deficit Disorder With Hyperactivity

Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Estimated Week 12 Self-reported Use — 2.17; 1.84 Times per day

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Atomoxetine (Drug); Motivational enhancement therapy (Procedure); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Medical University of South Carolina
Primary completion
Jun 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Estimated Week 12 Self-reported Use
2.17; 1.84
SECONDARY
Self-reported Longitudinal Use
60.1; 68.1
SECONDARY
Urine Drug Screens
87.3; 85.3
SECONDARY
Wender-Reimherr Adult Attention Deficit Disorder Scale
-15.05; -11.05
SECONDARY
Clinical Global Impression, Improvement Scale
2.63; 3.26

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Healthy men and women, 18 to 65 years of age
  • Meet DSM-IV criteria for marijuana dependence
  • Meet DSM-IV criteria for current ADHD, determined by a clinical interview and confirmed by semi-structured interview with the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAAR-D; Conners et al, 1999)
  • ADHD symptom severity indicated by a score of 12 or greater on the Wender-Reimherr Adult Attention Deficit Disorder Scale
  • ADHD symptoms must be corroborated by a second informant on either current symptoms (by a significant other or close friend) or childhood symptoms (by a parent or older sibling)
  • All subjects will agree to and sign a written, IRB-approved informed consent
  • Subjects must live within a 60-mile radius of Charleston, SC, to facilitate study visit compliance

Exclusion Criteria

  • Individuals meeting DSM-IV dependence for a substance other than marijuana with the exception of nicotine and caffeine. Dependence on nicotine and caffeine will be allowed since dependence on these substances commonly co-occurs with marijuana dependence and excluding these individuals would compromise study recruitment
  • Individuals meeting DSM-IV criteria for a lifetime history of schizophrenia or another non-affective psychotic disorder or bipolar disorder, since these patients will most likely be taking other psychotropic medications and often require intensive psychiatric care
  • Individuals meeting DSM-IV criteria for current major depressive disorder or eating disorder, since these individuals will likely require treatment with psychotropic medications. Subjects may meet criteria for a minor mood disorder (dysthymia) and for anxiety disorders. The inclusion of subjects with these disorders will be allowed as they commonly co-exist among patients with marijuana dependence (Stephens et al, 1993)
  • Individuals who present significant suicidal risk
  • Individuals with significant cognitive impairment as measured by a score of less than 26 on the Mini-Mental Status Exam, as they may be unable to understand the informed consent, comply with study protocol, or accurately complete assessments
  • Individuals currently receiving stimulants, benzodiazepines, antidepressant or antipsychotic medications, as these medications could confound the effects of atomoxetine treatment
  • Individuals currently receiving psychotherapy focusing on reducing marijuana use or on ADHD symptoms, as this could confound the effects of atomoxetine treatment. Participation in 12-step programs will be allowed
  • Pregnant or nursing women, or women who refuse to use adequate birth control, as atomoxetine has not been approved for use in pregnancy
  • Individuals without stable housing, as contacting these individuals would be difficult
  • Individuals with major medical illnesses (e.g., HIV, renal failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis)
  • Patients with hypertension (defined as having blood pressure greater than 140/90 measured on 3 or more occasions), as atomoxetine treatment can be associated with increases in blood pressure
  • Patients with evidence of hepatic insufficiency, as atomoxetine requires hepatic metabolism
  • Patients with urinary hesitancy or urinary hesitation, as atomoxetine has been associated with some urinary hesitation in clinical trials
  • Individuals who, in the investigators' opinion, would not be able to comply with study procedures, such as individuals unable to reliably present for intake appointments
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00360269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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