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

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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

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date May 21, 2018
Study Start Date  ICMJE December 2006
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
Use of cigarettes [ Time Frame: Day 15 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
Smoking Relapse, Day 15
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3
Official Title  ICMJE Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE Drug: Memantine
Study Arms  ICMJE
  • Placebo Comparator: Intervention 1

    Each participant receives three consecutive interventions.

    1. Placebo
    2. Bupropion
    3. Memantine
    Intervention: Drug: Memantine
  • Placebo Comparator: Intervention 2
    1. Bupropion
    2. Memantine
    3. Placebo
    Intervention: Drug: Memantine
  • Placebo Comparator: Intervention 3
    1. Memantine
    2. Placebo
    3. Bupropion
    Intervention: Drug: Memantine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2015)
25
Original Enrollment  ICMJE
 (submitted: August 25, 2005)
24
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136786
Other Study ID Numbers  ICMJE #4725(A)
R01DA017572 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adam Bisaga, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Adam Bisaga, M.D. New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP