NCT00136747

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 tobacco addiction. The investigators will compare the effects of memantine with bupropion, medication currently used to facilitate smoking cessation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

5.3 years

First QC Date

August 25, 2005

Last Update Submit

May 17, 2018

Conditions

Tobacco Use Disorder

Keywords

tobacco use

Outcome Measures

Primary Outcomes (2)

  • Response to cigarette cues

    Days 11-13

  • Smoking behavior

    Days 11-13

Study Arms (3)

BUPROPION

EXPERIMENTAL

Participants receive 20 mg bid of memantine, placebo, or bupropion in a double-blind crossover design and are maintained on active or placebo medication for 5 or 10 days before the inpatient testing

Drug: bupropion

placebo

EXPERIMENTAL

Participants receive 20 mg bid of memantine, placebo, or bupropion in a double-blind crossover design and are maintained on active or placebo medication for 5 or 10 days before the inpatient testing

Drug: placebo

memantine

EXPERIMENTAL

Participants receive 20 mg bid of memantine, placebo, or bupropion in a double-blind crossover design and are maintained on active or placebo medication for 5 or 10 days before the inpatient testing

Drug: Memantine

Interventions

MemantineDRUG

Two capsules of Memantine twice daily for 12 days.

memantine
bupropionDRUG
BUPROPION
placeboDRUG
placebo

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use

Interventions

MemantineBupropion

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropiophenonesKetones

Study Officials

  • Adam Bisaga, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

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

January 1, 2004

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

US(1)