Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT01329614
• Date of registration: 14/10/2010
• Primary sponsor: New York State Psychiatric Institute
• Public title: Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving
• Scientific title: Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving
• Date of first enrolment: October 2009
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01329614
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Laura R Shiffrin, BFA

• Name: S. Rob Vorel, M.D., Ph.D.
• Affiliation: New York State Psychiatric Institute, Substance Use Research Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.)



Age minimum: 21 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tobacco Use Disorder

Intervention(s)

Behavioral: Cue Extinction Therapy

Behavioral: Cue Extinction Training

Behavioral: Progressive Muscle Relaxation

Drug: Nicotine Replacement Therapy

Primary Outcome(s)

Galvanic Skin Response [Time Frame: 3 days, over the course of 4-5 weeks total.]

Secondary ID(s)

6001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors