Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3
3 other identifiers
interventional
25
1 country
1
Brief Summary
One of nicotine's effects on the body is at the level of the NMDA receptors in the brain. Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment of nicotine addiction. The purpose of this study is to evaluate the effectiveness of memantine using a laboratory model of smoking relapse in nicotine dependent volunteers. Investigators will compare the effects of memantine with bupropion, medication currently used to facilitate smoking cessation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2006
Typical duration for phase_1
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
First Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMay 21, 2018
May 1, 2018
2.4 years
August 25, 2005
May 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Use of cigarettes
Day 15
Study Arms (3)
Intervention 1
PLACEBO COMPARATOREach participant receives three consecutive interventions. 1. Placebo 2. Bupropion 3. Memantine
Intervention 2
PLACEBO COMPARATOR1. Bupropion 2. Memantine 3. Placebo
Intervention 3
PLACEBO COMPARATOR1. Memantine 2. Placebo 3. Bupropion
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV diagnosis of nicotine dependence with psychological dependence
- Smokes at least 15 cigarettes per day for the three months prior to enrollment
- Currently not seeking treatment for nicotine dependence
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests
- Females must use an effective method of contraception for the duration of the study
You may not qualify if:
- DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment
- History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
- Currently seeking treatment for nicotine disorders
- On parole or probation
- History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
- History of significant recent violent behavior
- Blood pressure greater than 150/90
- History of eating disorders
- History of allergic reaction to any of the study medications
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Bisaga, M.D.
New York State Psychiatric Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Psychiatrist
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
December 1, 2006
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
May 21, 2018
Record last verified: 2018-05