N/A
N=12
Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00136838 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Cigarette Choice After 3 Day Abstinence — 2.50; 3.67 number of cigarette choices (0-6)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neutral or active cigarette cues (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarette Choice After 3 Day Abstinence |
2.50; 3.67 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00136838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.