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Atomoxetine Treatment for ADHD and Marijuana Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360269
Recruitment Status : Completed
First Posted : August 4, 2006
Results First Posted : April 9, 2012
Last Update Posted : December 30, 2014
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

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 hyperactivity disorder and marijuana dependence.

Condition or disease Intervention/treatment Phase
Marijuana Abuse Attention Deficit Disorder With Hyperactivity Drug: Atomoxetine Procedure: Motivational enhancement therapy Drug: Placebo Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Active
Atomoxetine plus Motivational Enhancement Therapy
Drug: Atomoxetine
25 to 100 mg daily
Other Name: Strattera

Procedure: Motivational enhancement therapy
Three sessions
Other Name: MET

Placebo Comparator: Placebo
Placebo plus Motivational Enhancement Therapy
Procedure: Motivational enhancement therapy
Three sessions
Other Name: MET

Drug: Placebo
25 to 100 mg daily
Other Name: Sugar pill

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Urine Drug Screens [ Time Frame: 12 weeks ]
    Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.

  3. 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).

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00360269

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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Aimee L McRae, PharmD Medical University of South Carolina

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Aimee McRae-Clark, Associate Professor of Psychiatry, Medical University of South Carolina Identifier: NCT00360269     History of Changes
Obsolete Identifiers: NCT00227851
Other Study ID Numbers: R21DA018221 ( U.S. NIH Grant/Contract )
R21DA018221 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2006    Key Record Dates
Results First Posted: April 9, 2012
Last Update Posted: December 30, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Marijuana Abuse
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs