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Atomoxetine for the Treatment of Cannabis Dependence

Primary Purpose

Cannabis Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring atomoxetine, cannabis dependence, treatment

Eligibility Criteria

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

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • University of Pennsylvania Treatment Rersearch Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atomoxetine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2005
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00167297
Brief Title
Atomoxetine for the Treatment of Cannabis Dependence
Official Title
A Pilot Trial of Atomoxetine to Enhance Motivational Interviewing Therapy for the Treatment of Cannabis Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a Phase 2 open-label study. We will recruit 10 cannabis dependent subjects and treat them with the combination of Atomoxetine and MIT to reduce their consumption of cannabis. Subjects will be 10 men and women with current DSM-IV diagnosis of cannabis dependence. All patients will receive Atomoxetine and four sessions of MIT. The study length for each patient will be one week for baseline screening and starting medication. This is followed by 8 weeks of medication and an end of study visit one week after completing medications. The PI will review all information collected regarding the subject's eligibility for the study. The subject will return approximately four days later, and if the PI finds the subject suitable for the study, the subject will begin taking study medication. This visit is referred to as visit 2. During visit 2, the PI will monitor the subject for concomitant medications and adverse events. The research technician will collect Vital Signs, Weight, BAL, the TLFB, a Urine Tox Screen and THC/CR ratio. Both visits 1 and 2 will be conducted within the first week of the study. Starting at visit 2, subjects will take one 25mg capsule of Atomoxetine orally for seven days. Beginning at visit 3, subjects will increase the dose to 40mg per day for 3 days, followed by 80mg (two 40mg capsules concurrently) for the other four days of the second week. Beginning with week 3, subjects will take two 40mg capsules (80mg total) every day of the week for 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
Keywords
atomoxetine, cannabis dependence, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atomoxetine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Primary Outcome Measure Information:
Title
Marijuana use in patients treated with atomoxetine and Motivational Interviewing Therapy measured using weekly urine drug screens.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Tolerability of atomoxetine: Tolerability will be assessed by examining the rates of certain adverse events during the treatment phase.
Time Frame
8 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: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos F. Tirado, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Treatment Rersearch Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18182254
Citation
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.
Results Reference
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Atomoxetine for the Treatment of Cannabis Dependence

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