Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167297
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2005-09-09
Brief Title:
Atomoxetine for the Treatment of Cannabis Dependence
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
A Pilot Trial of Atomoxetine to Enhance Motivational Interviewing Therapy for the Treatment of Cannabis Dependence
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects 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 THCCR 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
The PI will review all information collected regarding the subjects 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 THCCR 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| T32MH019126-16 | NIH | None | httpsreporternihgovquickSearchT32MH019126-16 |
| P60DA005186-17 | NIH | None | None |
| T32MH019126-14 | NIH | None | None |
| T32MH019126-15 | NIH | None | None |