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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00136786
First received: August 25, 2005
Last updated: December 7, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Tobacco Use Disorder
Drug: Memantine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Use of cigarettes [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: December 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136786

Locations
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
Principal Investigator: Adam Bisaga, M.D. New York State Psychiatric Institute
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00136786     History of Changes
Other Study ID Numbers: #4725(A)  R01DA017572  DPMC 
Study First Received: August 25, 2005
Last Updated: December 7, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
tobacco use

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Bupropion
Memantine
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2016