Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals
Marijuana Pharmacotherapies: Controlled Clinical Trials With Nefazodone and Bupropion
4 other identifiers
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2000
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 3, 2005
CompletedFirst Posted
Study publicly available on registry
November 7, 2005
CompletedJanuary 16, 2017
March 1, 2011
4 years
November 3, 2005
January 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Marijuana use
Secondary Outcomes (1)
Marijuana withdrawal
Interventions
Eligibility Criteria
You may qualify if:
- Meets DSM-IV criteria for current marijuana dependence
- Uses at least 5 marijuana joints per week
- Currently seeking treatment for marijuana dependence
- Used marijuana in a maladaptive pattern in the 6 months prior to study entry
You may not qualify if:
- History of seizures or unexplained loss of consciousness
- Significant and unstable psychiatric condition (e.g., schizophrenia, bipolar disorder)
- Chronic organic mental disorder
- Dependent on any substances of abuse other than marijuana
- Currently at significant suicidal risk
- Unstable physical disorder that may represent a severe untreated condition, such as hypertension (blood pressure greater than 150/90), elevated transaminase levels, or unstable diabetes
- Current or suspected coronary vascular disease
- Has taken a monoamine oxidase inhibitor in the 2 weeks prior to study entry
- Currently taking terfenedine, cisapride, astemizole, or pimozide
- History of an allergic reaction to bupropion or nefazodone
- If female, pregnant, breastfeeding, or unwilling to use an adequate method of contraception for the duration of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Mcdowell, MD
New York State Psychiatric Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 3, 2005
First Posted
November 7, 2005
Study Start
September 1, 2000
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
January 16, 2017
Record last verified: 2011-03