NCT00167297

Brief Summary

The purpose of this small open-label trial is to evaluate the feasibility of recruiting cannabis dependent patients for treatment with Atomoxetine and MIT. The clinical data to date on Atomoxetine has been limited to children and adults with attention deficit disorder without co-morbid substance dependence. However, one study estimated that adults with attention deficit disorder have rates of drug abuse three to four times higher than controls (Mannuzza S 1998). The study also reported that cannabis and cocaine are most frequently abused in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_2

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, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

January 11, 2017

Status Verified

June 1, 2010

Enrollment Period

8 months

First QC Date

September 9, 2005

Last Update Submit

January 10, 2017

Conditions

Cannabis Dependence

Keywords

atomoxetinecannabis dependencetreatment

Outcome Measures

Primary Outcomes (1)

  • Marijuana use in patients treated with atomoxetine and Motivational Interviewing Therapy measured using weekly urine drug screens.

    8 weeks

Secondary Outcomes (1)

  • Tolerability of atomoxetine: Tolerability will be assessed by examining the rates of certain adverse events during the treatment phase.

    8 weeks

Study Arms (1)

Atomoxetine

EXPERIMENTAL

Atomoxetine (Strattera) 25mg peroral (PO) each day for seven days, then up to 40mb bid 40mg PO each day for three days, then 80mg PO bid.

Drug: Atomoxetine

Interventions

AtomoxetineDRUG
Atomoxetine

Eligibility Criteria

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

You may qualify if:

  • Males and females, 18-65 years old
  • Meets DSM-IV criteria for Cannabis Dependence
  • Live within a commutable distance of the Treatment Research Center
  • Understands and signs the informed consent

You may not qualify if:

  • Current DSM-IV diagnosis of any psychoactive substance dependence other than marijuana, or nicotine dependence
  • History of a learning disability
  • History of a diagnosis of ADHD made by a psychiatrist.
  • Concomitant treatment with psychotropic medications, especially Monoamine Oxidase Inhibitors
  • Mandated to treatment based upon a legal decision or as a condition of employment
  • Current severe psychiatric symptoms, e.g. psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring antidepressant therapy, or which could make it unsafe for the patient to participate in the opinion of the primary investigators.
  • Use of any investigational medication within the past 30 days
  • Current treatment with pressor agents or albuterol.
  • History of narrow angle glaucoma.
  • History of significant, unstable heart disease, including myocardial infarction, unstable angina, cardiac failure, second or third degree heart block, or uncontrolled hypertension
  • Known hypersensitivity to atomoxetine
  • Subjects with known AIDS or other serious illnesses, which may require hospitalization during the study
  • Female subjects who are pregnant or lactating, or female subjects of child bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include:
  • Barrier (diaphragm or condom) with spermicide Intrauterine device Levonorgestrel implant Medroxyprogesterone acetate contraceptive injection Oral contraceptives
  • Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the principal investigators. On EKG, 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed. Liver function tests (LFT's) \<5 times ULN without symptoms of liver disease are acceptable after thorough medical review.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Treatment Rersearch Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Tirado CF, Goldman M, Lynch K, Kampman KM, Obrien CP. Atomoxetine for treatment of marijuana dependence: a report on the efficacy and high incidence of gastrointestinal adverse events in a pilot study. Drug Alcohol Depend. 2008 Apr 1;94(1-3):254-7. doi: 10.1016/j.drugalcdep.2007.10.020. Epub 2008 Jan 7.

    PMID: 18182254RESULT

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Carlos F. Tirado, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

November 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

January 11, 2017

Record last verified: 2010-06

Locations

US(1)