D-cycloserine (DCS) Pretreatment + CBT + Nicotine Replacement Therapy for Smoking Cessation (DCS) (DCS)

August 1, 2018 updated by: Kevin P. Hill, MD, MHS, Mclean Hospital

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

  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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-cycloserine
250 mg D-cycloserine once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy.
Behavioral: Cognitive Behavioral Therapy
CBT administered to to both DCS and placebo group.
Other Names:
  • CBT
Drug: Nicotine Replacement Therapy
NRT administered to both DCS and placebo group.
Other Names:
  • NRT
Placebo Comparator: Placebo
one placebo capsule once weekly an hour before receiving cognitive behavioral therapy treatment along with Nicotine Replacement Therapy
Behavioral: Cognitive Behavioral Therapy
CBT administered to to both DCS and placebo group.
Other Names:
  • CBT
Drug: Nicotine Replacement Therapy
NRT administered to both DCS and placebo group.
Other Names:
  • NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Cigarette Smoking in Treatment Seeking Nicotine Dependent Outpatients
Time Frame: During Week 10
Cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.
During Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Collaborators

American Lung Association

Investigators

  • Principal Investigator: Kevin P. Hill, MD, MHS, McLean Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 25, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (Estimate)

April 29, 2013

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P001707

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on Cognitive Behavioral Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe