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

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ClinicalTrials.gov Identifier: NCT01842334
Recruitment Status : Terminated (left institution protocol closed)
First Posted : April 29, 2013
Results First Posted : August 1, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital

Brief Summary:
  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 or disease Intervention/treatment Phase
Nicotine Dependence Smoking Cessation Behavioral: Cognitive Behavioral Therapy Drug: Nicotine Replacement Therapy Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: D-cycloserine (DCS) Pretreatment + Cognitive Behavioral Therapy and Nicotine Replacement Therapy for Smoking Cessation
Actual Study Start Date : April 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


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 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 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 Name: CBT

Drug: Nicotine Replacement Therapy
NRT administered to both DCS and placebo group.
Other Name: NRT




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842334


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
American Lung Association
Investigators
Principal Investigator: Kevin P. Hill, MD, MHS Mclean Hospital
  Study Documents (Full-Text)

Documents provided by Kevin P. Hill, MD, MHS, Mclean Hospital:

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
First Posted: April 29, 2013    Key Record Dates
Results First Posted: August 1, 2018
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Kevin P. Hill, MD, MHS, Mclean Hospital:
Nicotine Dependence
Smoking Cessation
D-cycloserine

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