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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Mclean Hospital
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01842334
First received: April 25, 2013
Last updated: April 26, 2013
Last verified: April 2013
  Purpose
  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.

Condition Intervention Phase
Nicotine Dependence
Smoking Cessation
Behavioral: Cognitive Behavioral Therapy
Drug: Nicotine Replacement Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: D-cycloserine (DCS) Pretreatment + Cognitive Behavioral Therapy and Nicotine Replacement Therapy for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Change from baseline in cigarette smoking in treatment seeking nicotine dependent outpatients [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    Change from baseline in cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D-cycloserine
250 mg D-cycloserine once weekly
Behavioral: Cognitive Behavioral Therapy
CBT administered to to both DCS and placebo group.
Other Name: CBT
Drug: Nicotine Replacement Therapy
NRT administered to both DCS and placebo group.
Other Name: NRT
Placebo Comparator: Placebo
one placebo capsule once weekly
Behavioral: Cognitive Behavioral Therapy
CBT administered to to both DCS and placebo group.
Other Name: CBT
Drug: Nicotine Replacement Therapy
NRT administered to both DCS and placebo group.
Other Name: NRT

Detailed Description:

The investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to develop a medication to treat nicotine dependence. In a randomized, double-blind, placebo-controlled trial, 40 nicotine-dependent participants ages 18-65 will receive cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT) over a 10- week period, with half receiving D-cycloserine (DCS) pretreatment and half receiving placebo. Participants will receive either 250 mg DCS or placebo prior to weekly CBT sessions in addition to NRT over a 10-week treatment period. The investigators also aim to determine the effects of DCS on performance on neuropsychological tests. A 10-week treatment period will be followed by follow-up assessments including neuropsychological tests at 1 and 3 months post-treatment. Primary outcomes will include smoking as measured by carbon monoxide levels and self-report measurements.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 treatment;9) current CBT for smoking cessation; 10) current smokeless tobacco use; 11) inability to read or write in English;12) has epilepsy.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842334

Contacts
Contact: William M. Hurley-Welljams-Dorof, B.S. 617-855-3156 wdorof@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: William M. Hurley-Welljams-Dorof, B.S.    617-855-3156    wdorof@mclean.harvard.edu   
Principal Investigator: Kevin P. Hill, MD, MHS         
Sponsors and Collaborators
Mclean Hospital
American Lung Association
Investigators
Principal Investigator: Kevin P. Hill, MD, MHS Mclean Hospital
  More Information

No publications provided

Responsible Party: Kevin P. Hill, MD, MHS, Assistant Professor of Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01842334     History of Changes
Other Study ID Numbers: 2012P001707
Study First Received: April 25, 2013
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Nicotine Dependence
Smoking Cessation
D-cycloserine

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cycloserine
Nicotine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 28, 2014