D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation (DCSSmoking)

D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation

This study examines whether isolated doses of D-cycloserine enhance the efficacy of CBT for smoking cessation.

Study Overview

• Status: Withdrawn
• Conditions: Smokers
• Intervention / Treatment: Drug: D-cycloserine; Drug: Placebo

Detailed Description

In comparison to placebo-augmented cognitive behavioral therapy (CBT), D-cycloserine-augmented CBT will lead to a greater reduction in both short-and long-term point prevalence abstinence as well as time to first smoking lapse and time to smoking relapse.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be a regular smoker for at least one year 3. Currently smoke an average of at least 10 cigarettes per day 4. Report a motivation to quit smoking in the next month of at least 5 on a 10 point scale 5. Score 20 or greater on the 16-item Anxiety Sensitivity Index (Schmidt & Joiner, 2002).

Exclusion Criteria:

1. Current diagnosis of a psychotic, eating, developmental or bipolar disorder (as determined by the SCID)
2. Current anxiety or mood disorder rated moderate or greater (i.e., CGI score of 4 or greater for an anxiety or depressive disorder or any current or recent-1 year--suicidal ideation)
3. Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
4. Current use of isoniazid psychotropic medication
5. A history of significant medical condition, such as cardiovascular, neurologic, gastrointestinal, pregnancy and/or breast feeding, history of seizure (other than febrile seizures in childhood) or other systemic illness and/or be deemed as currently unhealthy in the context of a complete physical examination
6. Limited mental competency and the inability to give informed, voluntary, written consent to participate,
7. Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt,
8. Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of anxiety or mood disorder other than general supportive therapy initiated at least 3 months prior to the study
9. Use of other tobacco products
10. Planning on moving (outside of the immediate area) in the next six months
11. Insufficient command of the English language (i.e., they cannot carry on a conversation with an interviewer in the English language or read associated text).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; DCS-augmented CBT for smoking cessation	Drug: D-cycloserine; Single dosage prior to sessions 3, 4 & 5; Other Names: DCS
Placebo Comparator: 2; Placebo-augmented CBT for smoking cessation	Drug: Placebo; Single dosage prior to sessions 3, 4 & 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Carbon monoxide analysis	Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29
Cotinine levels in saliva	Baseline, Weeks 21 & 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Anxiety Sensitivity Index	Baseline, Weeks 5, 6, 7, 8, 9, 13, 21 & 29
Minnesota Withdrawal Scale	Each visit
Mood & Anxiety Symptom Questionnaire	Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, & 8
Smoking Cessation Self-Efficacy	Baseline, Weeks 3, 4, 5, 6, 7, 8, 9, 13, 21 & 29

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2008
• Primary Completion (Actual): July 15, 2015
• Study Completion (Actual): July 15, 2015

Study Registration Dates

• First Submitted: January 21, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: smoking; tobacco; CBT; DCS
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Anti-Bacterial Agents; Antitubercular Agents; Antibiotics, Antitubercular; Anti-Infective Agents, Urinary; Renal Agents; Cycloserine
• Other Study ID Numbers: 1728