Atomoxetine Treatment for ADHD and Marijuana Dependence
Condition: Marijuana Abuse; Attention Deficit Disorder With Hyperactivity
MeSH terms: Marijuana Abuse; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine; Motivational enhancement therapy; Placebo
Intervention description: 25 to 100 mg daily; Three sessions; 25 to 100 mg daily
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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:

          1. Healthy men and women, 18 to 65 years of age

          2. Meet DSM-IV criteria for marijuana dependence

          3. 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)

          4. ADHD symptom severity indicated by a score of 12 or greater on the Wender-Reimherr
             Adult Attention Deficit Disorder Scale

          5. 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)

          6. All subjects will agree to and sign a written, IRB-approved informed consent

          7. Subjects must live within a 60-mile radius of Charleston, SC, to facilitate study
             visit compliance

        Exclusion Criteria:

          1. 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

          2. 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

          3. 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)

          4. Individuals who present significant suicidal risk

          5. 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

          6. Individuals currently receiving stimulants, benzodiazepines, antidepressant or
             antipsychotic medications, as these medications could confound the effects of
             atomoxetine treatment

          7. 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

          8. Pregnant or nursing women, or women who refuse to use adequate birth control, as
             atomoxetine has not been approved for use in pregnancy

          9. Individuals without stable housing, as contacting these individuals would be difficult

         10. Individuals with major medical illnesses (e.g., HIV, renal failure, unstable angina,
             chronic obstructive pulmonary disease, infectious hepatitis)

         11. 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

         12. Patients with evidence of hepatic insufficiency, as atomoxetine requires hepatic
             metabolism

         13. Patients with urinary hesitancy or urinary hesitation, as atomoxetine has been
             associated with some urinary hesitation in clinical trials

         14. 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