Status:
COMPLETED
Atomoxetine Treatment for ADHD and Marijuana Dependence
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Marijuana Abuse
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 hyperact...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00360269
Start Date
November 1 2005
End Date
June 1 2008
Last Update
December 30 2014
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425