Attention Deficit Disorder With Hyperactivity Clinical Trial
Official title:
Atomoxetine Treatment for ADHD and Marijuana Dependence
Verified date | December 2014 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimated Week 12 Self-reported Use | Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back. | One week (study week 12) | No |
Secondary | Self-reported Longitudinal Use | 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. | 12 weeks | No |
Secondary | Urine Drug Screens | Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group. | 12 weeks | No |
Secondary | Wender-Reimherr Adult Attention Deficit Disorder Scale | 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). | Baseline and Week 12 | No |
Secondary | Clinical Global Impression, Improvement Scale | 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. | 12 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00202605 -
Safety and Efficacy of SPD465 in Adults With ADHD
|
Phase 2 | |
Not yet recruiting |
NCT02677519 -
A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD
|
Phase 4 | |
Completed |
NCT02730572 -
Concerta (Methylphenidate) -To-Generic Switch Study
|
N/A | |
Completed |
NCT01681082 -
Psychological Effects of Tai Chi Training
|
N/A | |
Active, not recruiting |
NCT01330693 -
Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy
|
Phase 3 | |
Completed |
NCT00830700 -
Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study
|
N/A | |
Completed |
NCT00626236 -
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
|
Phase 2 | |
Completed |
NCT01012622 -
An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD)
|
Phase 4 | |
Completed |
NCT00598182 -
Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study
|
N/A | |
Completed |
NCT00381407 -
Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
|
N/A | |
Completed |
NCT00247572 -
Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories
|
Phase 2 | |
Completed |
NCT00178503 -
Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
|
Phase 2/Phase 3 | |
Completed |
NCT00218322 -
Effectiveness of ATMX in Treating Adolescents With ADHD and SUD
|
Phase 4 | |
Completed |
NCT00118911 -
Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
|
N/A | |
Completed |
NCT00557011 -
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
|
Phase 2 | |
Completed |
NCT00071656 -
Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I
|
N/A | |
Active, not recruiting |
NCT00057668 -
Preventing Behavior Problems in Children With ADHD
|
Phase 2 | |
Completed |
NCT00050050 -
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
|
Phase 1 | |
Completed |
NCT00050622 -
Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT00031395 -
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
|
Phase 3 |