D-cycloserine (DCS) Pretreatment + Cognitive Behavioral Therapy and Nicotine Replacement Therapy for Smoking Cessation (DCS)

Description

1. Compare the relative efficacy of ten weeks of once weekly 250 mg D-cycloserine (DCS) vs. placebo (both in conjunction with cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT) on reducing cigarette smoking in treatment-seeking nicotine-dependent outpatients.

2. Compare the relative efficacy of ten weeks of once weekly 250 mg DCS vs. placebo on the process of extinction and the memory encoding process.

Study Start Date

April 2013

Estimated Completion Date

March 2016

Interventions

  • Drug: Nicotine Replacement Therapy
  • Behavioral: Cognitive Behavioral Therapy

Specialties

  • Psychiatry: Neuro/Psych Pharmacol,Psychotherapy/analysis,Substance Abuse
  • Family Medicine: Clinical Pharmacology,Substance Abuse
  • Pharmacy: Drug Trials,Neuro/Psych pharmacology
  • Nurse Practitioner: Clinical Pharmacology,Substance Abuse

MeSH Terms

  • Cognitive Therapy
  • D-cycloserine
  • Nicotine Replacement Therapy
  • Smoking Cessation

Study ID

Mclean Hospital -- 2012P001707

Status

Unknown

Trial ID

NCT01842334

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

40

Sponsor

Mclean Hospital

Inclusion Criteria

    1) Age range 18-65 years 2) DSM-IV diagnosis of nicotine dependence, based on the Structured Clinical Interview for DSM-IV (SCID) (First et al. 1996) 3) express a desire to quit cigarette smoking within the next 30 days 4) smokes greater than or equal to 10 cigarettes per day and less than or equal to 20 cigarettes per day 5) an expired carbon monoxide (CO) determination greater than or equal to 10 ppm over ambient values 6) for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and multiple subsequent pregnancy tests 7) consent for us to communicate with their prescribing clinician 8) furnish the names of 2 locators, who would assist study staff in locating them during the study period 9) live close enough to McLean Hospital to attend study visits 10) plan to remain in the Boston area for the next 4 months and 11) are willing and able to sign informed consent.

Exclusion Criteria

    1) Current diagnosis of other drug or alcohol dependence (other than nicotine) 2) significant cardiac disease 3) current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder (taking psychiatric medications, aside from wellbutrin, is not an exclusionary criterion) 4) have a current medical condition (including significant laboratory abnormalities, such as liver function tests >5 times the upper limit of normal range) that could prevent regular study attendance 5) have mental retardation or organic mental disorder 6) exhibit acutely dangerous or suicidal behavior 7) are pregnant, nursing, or, if a woman of childbearing potential, not using a form of birth control judged by the Principal Investigator to be effective 8) current NRT or other smoking cessation treatment9) current CBT for smoking cessation 10) current smokeless tobacco use 11) inability to read or write in English12) has epilepsy.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
McLean Hospital - Belmont, Massachusetts 4.7 miles William M HurleyWelljamsDorof BS 617-855-3156 wdorof@mclean.harvard.edu

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