search
Back to results

Atomoxetine Treatment for ADHD and Marijuana Dependence

Primary Purpose

Marijuana Abuse, Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Motivational enhancement therapy
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Atomoxetine plus Motivational Enhancement Therapy

Placebo plus Motivational Enhancement Therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Urine Drug Screens
Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.
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).
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.

Full Information

First Posted
August 2, 2006
Last Updated
December 8, 2014
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00360269
Brief Title
Atomoxetine Treatment for ADHD and Marijuana Dependence
Official Title
Atomoxetine Treatment for ADHD and Marijuana Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse, Attention Deficit Disorder With Hyperactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Atomoxetine plus Motivational Enhancement Therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo plus Motivational Enhancement Therapy
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
25 to 100 mg daily
Intervention Type
Procedure
Intervention Name(s)
Motivational enhancement therapy
Other Intervention Name(s)
MET
Intervention Description
Three sessions
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
25 to 100 mg daily
Primary Outcome Measure Information:
Title
Estimated Week 12 Self-reported Use
Description
Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back.
Time Frame
One week (study week 12)
Secondary Outcome Measure Information:
Title
Self-reported Longitudinal Use
Description
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.
Time Frame
12 weeks
Title
Urine Drug Screens
Description
Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.
Time Frame
12 weeks
Title
Wender-Reimherr Adult Attention Deficit Disorder Scale
Description
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).
Time Frame
Baseline and Week 12
Title
Clinical Global Impression, Improvement Scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee L McRae, PharmD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29489073
Citation
Chauchard E, Hartwell KJ, McRae-Clark AL, Sherman BJ, Gorelick DA. Cannabis Withdrawal in Adults With Attention-Deficit/Hyperactivity Disorder. Prim Care Companion CNS Disord. 2018 Feb 22;20(1):17m02203. doi: 10.4088/PCC.17m02203.
Results Reference
derived

Learn more about this trial

Atomoxetine Treatment for ADHD and Marijuana Dependence

We'll reach out to this number within 24 hrs