NCT00136838

Brief Summary

Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. The purpose of this study is to develop a laboratory model for early-stage testing of new and existing treatments for nicotine addiction. Specifically, the investigators will develop a laboratory model of relapse to cigarette use in nicotine dependent volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

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

October 1, 2001

Completed
3.9 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
10 years until next milestone

Results Posted

Study results publicly available

May 11, 2016

Completed
Last Updated

June 18, 2018

Status Verified

May 1, 2018

Enrollment Period

4.7 years

First QC Date

August 25, 2005

Results QC Date

April 14, 2015

Last Update Submit

May 17, 2018

Conditions

Tobacco Use Disorder

Keywords

tobacco use

Outcome Measures

Primary Outcomes (1)

  • Cigarette Choice After 3 Day Abstinence

    Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices

    During Day 4 experimental session

Other Outcomes (1)

  • Craving

    immediately following cue expose

Study Arms (2)

Neutral Cue first, then Active Cue

EXPERIMENTAL

Each participant receives two consecutive interventions. 1. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue 2. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.

Behavioral: Neutral or active cigarette cues

Active Cue first, then Neutral Cue

EXPERIMENTAL

Each participant receives two consecutive interventions. 1. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue. 2. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue

Behavioral: Neutral or active cigarette cues

Interventions

Neutral or active cigarette cuesBEHAVIORAL

Packets of cigarettes or cigarette smoke.

Active Cue first, then Neutral CueNeutral Cue first, then Active Cue

Eligibility Criteria

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

You may qualify if:

  • 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:

  • Diagnosis of abuse or dependence on alcohol or drugs other than nicotine
  • Current Axis I diagnosis or current treatment with psychotropic medications within the 3 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
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Results Point of Contact

Title
Dr. Adam Bisaga
Organization
New York State Psychiatric Institute
bisagaa@nyspi.columbia.edu
646-774-6155

Study Officials

  • Adam Bisaga, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
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

October 1, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

June 18, 2018

Results First Posted

May 11, 2016

Record last verified: 2018-05

Locations

US(1)