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

NCT00827281 | Withdrawn Phase 2

• 1 other identifier: 1728
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smokers

Keywords

DCS; CBT; smoking; tobacco

Outcome Measures

Primary Outcomes (2)

• Carbon monoxide analysis

  Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29

• Cotinine levels in saliva

  Baseline, Weeks 21 & 29

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

DCS-augmented CBT for smoking cessation

Drug: D-cycloserine

2

PLACEBO COMPARATOR

Placebo-augmented CBT for smoking cessation

Drug: Placebo

Interventions

D-cycloserine DRUG

Single dosage prior to sessions 3, 4 \& 5

Also known as: DCS

1

Placebo DRUG

Single dosage prior to sessions 3, 4 \& 5

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).

You may not qualify if:

• Current diagnosis of a psychotic, eating, developmental or bipolar disorder (as determined by the SCID)
• 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)
• Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
• Current use of isoniazid psychotropic medication
• 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
• Limited mental competency and the inability to give informed, voluntary, written consent to participate,
• Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt,
• 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
• Use of other tobacco products
• Planning on moving (outside of the immediate area) in the next six months
• 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).

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: August 1, 2008
• Primary Completion: July 15, 2015
• Study Completion: July 15, 2015
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

US (1)