Atomoxetine Treatment for ADHD and Marijuana Dependence
This study has been completed.
Sponsor:
Medical University of South Carolina
Collaborator:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00360269
First received: August 2, 2006
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Marijuana Abuse Attention Deficit Disorder With Hyperactivity |
Drug: Atomoxetine Procedure: Motivational enhancement therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Atomoxetine Treatment for ADHD and Marijuana Dependence |
Resource links provided by NLM:
Further study details as provided by Medical University of South Carolina:
Primary Outcome Measures:
- Estimated Week 12 Self-reported Use [ Time Frame: One week (study week 12) ] [ Designated as safety issue: No ]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:
- Self-reported Longitudinal Use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Urine Drug Screens [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Urine drug screen (UDS), positive or negative for marijuana
- Wender-Reimherr Adult Attention Deficit Disorder Scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]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).
- Clinical Global Impression, Improvement Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 38 |
| Study Start Date: | November 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Atomoxetine
|
Drug: Atomoxetine
25 to 100 mg daily
Procedure: Motivational enhancement therapy
Three sessions
|
|
Placebo Comparator: B
Placebo
|
Procedure: Motivational enhancement therapy
Three sessions
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360269
Locations
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
Sponsors and Collaborators
Medical University of South Carolina
Investigators
| Principal Investigator: | Aimee L McRae, PharmD | Medical University of South Carolina |
More Information
No publications provided
| Responsible Party: | Aimee McRae-Clark, Associate Professor of Psychiatry, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00360269 History of Changes |
| Obsolete Identifiers: | NCT00227851 |
| Other Study ID Numbers: | R21DA018221, R21DA018221 |
| Study First Received: | August 2, 2006 |
| Results First Received: | November 7, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Marijuana Abuse Attention Deficit Disorder with Hyperactivity Hyperkinesis Substance-Related Disorders Mental Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Dyskinesias Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Atomoxetine Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013