NCT00360269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

April 9, 2012

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

2.6 years

First QC Date

August 2, 2006

Results QC Date

November 7, 2011

Last Update Submit

December 8, 2014

Conditions

Marijuana AbuseAttention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • Self-reported Longitudinal Use

    12 weeks

  • Urine Drug Screens

    12 weeks

  • Wender-Reimherr Adult Attention Deficit Disorder Scale

    Baseline and Week 12

  • Clinical Global Impression, Improvement Scale

    12 weeks

Study Arms (2)

Active

EXPERIMENTAL

Atomoxetine plus Motivational Enhancement Therapy

Drug: AtomoxetineProcedure: Motivational enhancement therapy

Placebo

PLACEBO COMPARATOR

Placebo plus Motivational Enhancement Therapy

Procedure: Motivational enhancement therapyDrug: Placebo

Interventions

AtomoxetineDRUG

25 to 100 mg daily

Also known as: Strattera
Active
Motivational enhancement therapyPROCEDURE

Three sessions

Also known as: MET
ActivePlacebo
PlaceboDRUG

25 to 100 mg daily

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

    PMID: 29489073DERIVED

MeSH Terms

Conditions

Marijuana AbuseAttention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine HydrochlorideMotivational InterviewingSugars

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesCarbohydrates

Limitations and Caveats

Small sample size and poor retention

Results Point of Contact

Title
Aimee McRae-Clark, Pharm.D., BCPP
Organization
Medical University of South Carolina
mcraeal@musc.edu
843-792-5215

Study Officials

  • Aimee L McRae, PharmD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

August 2, 2006

First Posted

August 4, 2006

Study Start

November 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 30, 2014

Results First Posted

April 9, 2012

Record last verified: 2014-12

Locations

US(1)