Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249509
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2005-11-03
Brief Title:
Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Marijuana Pharmacotherapies Controlled Clinical Trials With Nefazodone and Bupropion
Status:
COMPLETED
Status Verified Date:
2011-03
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:
Recent research has identified the following withdrawal symptoms to be associated with abruptly stopping marijuana use anxiety irritability bodily aches and pains and difficulty sleeping These symptoms resemble those of both depression and nicotine withdrawal suggesting that a similar treatment drug may be useful This study will evaluate the effectiveness of two antidepressant drugs bupropion and nefazodone in reducing withdrawal symptoms in marijuana dependent individuals
Detailed Description:
There have been few controlled studies that focus on treatments for marijuana dependence The symptoms associated with marijuana withdrawal including anxiety irritability bodily aches and pains and difficulty sleeping resemble those caused by depression and nicotine withdrawal Therefore antidepressant or nicotine withdrawal medications may be effective in treating marijuana dependence Nefazodone and bupropion are two medications currently used to treat depression The purpose of this study is to determine the effectiveness of nefazodone and bupropion in alleviating marijuana withdrawal symptoms In addition this study will evaluate whether these medications successfully treat marijuana dependent individuals in terms of treatment adherence and drug abstinence
Participants in this double-blind trial will be randomly assigned to receive nefazodone bupropion or placebo Daily doses of medication will be provided to participants in dated pill boxes pill boxes will then be returned to the study nurse at each study visit Medication will be taken in three daily doses one of the doses will be a nonmedicated pill Nefazodone will initially be given at a dose of 150 mg per day which participants will take at bedtime Every 5 days the daily dose will increase by 150 mg to a maximal dose of 600 mg of nefazodone per day Bupropion will be given at an initial dose of 150 mg which participants will take in the morning After 3 days the daily dose will increase to a total dose of 300 mg of bupropion per day
Study visits will occur daily at which time participants will complete drug use and withdrawal symptom reports In addition participants will partake in weekly therapy visits which will consist of four sessions of motivational enhancement therapy followed by sessions of relapse prevention therapy Bi-weekly psychiatry visits will include evaluations on substance use behavior and overall clinical symptoms and will last 15-30 minutes
Participants in this double-blind trial will be randomly assigned to receive nefazodone bupropion or placebo Daily doses of medication will be provided to participants in dated pill boxes pill boxes will then be returned to the study nurse at each study visit Medication will be taken in three daily doses one of the doses will be a nonmedicated pill Nefazodone will initially be given at a dose of 150 mg per day which participants will take at bedtime Every 5 days the daily dose will increase by 150 mg to a maximal dose of 600 mg of nefazodone per day Bupropion will be given at an initial dose of 150 mg which participants will take in the morning After 3 days the daily dose will increase to a total dose of 300 mg of bupropion per day
Study visits will occur daily at which time participants will complete drug use and withdrawal symptom reports In addition participants will partake in weekly therapy visits which will consist of four sessions of motivational enhancement therapy followed by sessions of relapse prevention therapy Bi-weekly psychiatry visits will include evaluations on substance use behavior and overall clinical symptoms and will last 15-30 minutes
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 |
|---|---|---|---|
| R01-DA013191-1 | None | None | None |
| DPMC | None | None | None |