Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

NCT01329614 | Completed Early Phase 1 DMC

• 2 other identifiers: 6001K23DA025735
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Cue Extinction Training will reduce relapse rates in cigarette smokers using the patch to quit.

Conditions

Tobacco Use Disorder

Keywords

Tobacco; Nicotine; Cigarette

Outcome Measures

Primary Outcomes (1)

• Galvanic Skin Response

  Measurements of Galvanic Skin Response (GSR) are taken while participant is exposed to the cue. The amount of change in GSR is used to determine CET's impact on cigarette craving.

  3 days, over the course of 4-5 weeks total.

Study Arms (4)

Nicotine Replacement Therapy, 7mg dose

EXPERIMENTAL

Behavioral: Cue Extinction Training; Drug: Nicotine Replacement Therapy; Behavioral: Cue Extinction Therapy; Behavioral: Progressive Muscle Relaxation

Nicotine Replacement Therapy, 21mg dose

EXPERIMENTAL

Behavioral: Cue Extinction Training; Drug: Nicotine Replacement Therapy; Behavioral: Cue Extinction Therapy; Behavioral: Progressive Muscle Relaxation

Nicotine Replacement Therapy, Placebo

PLACEBO COMPARATOR

Behavioral: Cue Extinction Training; Behavioral: Cue Extinction Therapy; Behavioral: Progressive Muscle Relaxation

Nicotine Replacement Therapy, 42mg dose

EXPERIMENTAL

Behavioral: Cue Extinction Training; Drug: Nicotine Replacement Therapy; Behavioral: Cue Extinction Therapy; Behavioral: Progressive Muscle Relaxation

Interventions

Cue Extinction Training BEHAVIORAL

Repeated exposure to cigarette cues while receiving Nicotine Replacement Therapy.

Nicotine Replacement Therapy, 21mg dose; Nicotine Replacement Therapy, 42mg dose; Nicotine Replacement Therapy, 7mg dose; Nicotine Replacement Therapy, Placebo

Nicotine Replacement Therapy DRUG

Study doctor applies a nicotine patch to the participant's shoulder blade. The patch dose is blinded by placement of a Bandaid over the patch itself.

Also known as: Nicoderm CQ

Nicotine Replacement Therapy, 21mg dose; Nicotine Replacement Therapy, 42mg dose; Nicotine Replacement Therapy, 7mg dose

Cue Extinction Therapy BEHAVIORAL

Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.

Nicotine Replacement Therapy, 21mg dose; Nicotine Replacement Therapy, 42mg dose; Nicotine Replacement Therapy, 7mg dose; Nicotine Replacement Therapy, Placebo

Progressive Muscle Relaxation BEHAVIORAL

Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.

Nicotine Replacement Therapy, 21mg dose; Nicotine Replacement Therapy, 42mg dose; Nicotine Replacement Therapy, 7mg dose; Nicotine Replacement Therapy, Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A DSM-IV Diagnosis of nicotine dependence with physiological dependence. Smoke at least 15 cigarettes daily for two years.
• Not interested in treatment.
• Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.
• Able to perform study procedures.
• Males or females between the ages of 21-60 years.
• Female participants agree to use an effective method of birth control during the course of the study.

You may not qualify if:

• A 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 last 3 months).
• Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders.
• Seeking treatment for nicotine dependence.
• Participants on parole or probation.
• History of significant recent violent behavior.
• Unstable medical condition, Blood Pressure \> 150/90, Pregnancy.
• History of allergic reaction to nicotine patch.
• Participants with significant cardiac history (i.e. angina pectoris, bypass surgery, or coronary artery disease.)

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute - Substance Use Research Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine Replacement Therapy; Nicotine; Autogenic Training

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Hypnosis; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• S. Rob Vorel, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: April 6, 2011
• Study Start: October 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (1)