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Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00136786
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Adam Bisaga, New York State Psychiatric Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Memantine Phase 1

Detailed Description:

Tobacco use is the leading preventable cause of death in the United States. Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. Neurotransmission at NMDA receptors in the brain is associated with learning and memory and has been linked to many of nicotine's effects on humans. It is possible that altering NMDA neurotransmission may be helpful in treating nicotine addiction. The goal of this study is to evaluate the effects of memantine, an NMDA receptor antagonist, using the laboratory model of smoking relapse in nicotine dependent volunteers. The effects of memantine used in combination with bupropion, a medication currently used to facilitate smoking cessation, will be compared to a placebo.

This double-blind study will consist of three phases (placebo, bupropion, and memantine). Each phase will include 10 days of outpatient medication maintenance, followed by 5 days of inpatient testing. During the outpatient phase, study visits will occur every 2 to 3 days. During the first portion of inpatient stay, participants will not be permitted to smoke. During the second portion of inpatient stay, smoking reinstatement will be modeled, as participant will have opportunity to smoke. A variety of behavioral, subjective, physiological, and performance measures will be assessed throughout the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals
Study Start Date : December 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Intervention 1

Each participant receives three consecutive interventions.

  1. Placebo
  2. Bupropion
  3. Memantine
 Drug: Memantine
Placebo Comparator: Intervention 2
  1. Bupropion
  2. Memantine
  3. Placebo
 Drug: Memantine
Placebo Comparator: Intervention 3
  1. Memantine
  2. Placebo
  3. Bupropion
 Drug: Memantine


Outcome Measures
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Primary Outcome Measures :
  1. Use of cigarettes [ Time Frame: Day 15 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136786


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Adam Bisaga, M.D. New York State Psychiatric Institute
More Information
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Responsible Party: Adam Bisaga, Research Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00136786    
Other Study ID Numbers: #4725(A)
R01DA017572 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Keywords provided by Adam Bisaga, New York State Psychiatric Institute:
tobacco use
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents