Investigation of Cycloserine as a Smoking Cessation Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard De La Garza, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01062932
First received: February 3, 2010
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

Psychosocial treatments for drug abuse benefit some patients (Rawson et al 2004), but there is an urgent need for new treatment approaches that can improve treatment outcomes. One new approach involves facilitation of extinction of conditioned responses through the use of d-cycloserine, a partial agonist at the NMDA glycine site. This approach has proved useful for the treatment of several anxiety disorders. For example, treatment with d-cycloserine enhanced the efficacy of behavioral treatments for acrophobia (Ressler et al 2004) and social phobia (Hofmann et al 2006) by enhancing extinction of conditioned fear responses. This suggests that d-cycloserine has potential to enhance the efficacy of behavioral treatments for drug dependence by enhancing extinction of conditioned responses to drug cues. In this Phase I Cutting-Edge Basic Research Awards (CEBRA) application we propose a proof-of-concept study to examine effects of treatment with d-cycloserine for facilitating extinction of craving provoked by exposure to cigarette smoking cues. The benefits of this treatment approach together with cognitive behavioral treatment for reducing cigarette smoking will then be determined. Smoking cues will be presented using an established virtual reality simulator(Bordnick et al 2004; Bordnick et al 2005a)


Condition Intervention Phase
Nicotine Addiction
Drug: Cycloserine
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Cycloserine Enhancement of Extinction Learning

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • The effects of four weeks of single dose treatment with d-cycloserine or placebo on craving elicited by exposure to "virtual reality" smoking cues [ Designated as safety issue: No ]
    The study will evaluate the effects of treatment with d-cycloserine (50mg administered prior to each exposure treatment) or placebo (n=20 per cell), on the efficacy exposure therapy using a virtual reality cue for smoking cessation when combined with cognitive behavioral therapy (CBT). Craving ratings will be assessed using standard questionnaires, which will be completed prior to and following virtual reality cue exposure. Smoking cessation and cocaine use will be assessed at three follow-up visits.


Secondary Outcome Measures:
  • The effects of four weeks of single dose treatment with d-cycloserine or placebo, exposure to virtual reality smoking cues, and provision of manual-driven cognitive behavioral treatment on frequency of cigarette smoking and cocaine use [ Designated as safety issue: No ]
    Study sessions will include assessment of urinary cocaine and breath CO, and participants will self-report cigarette smoking and cocaine use over the previous week. Smoking cessation and cocaine use will also be assessed at three follow-up visits.


Enrollment: 34
Study Start Date: May 2009
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Oral administration of matching placebo pill on Days 1, 4, 7, and 10
Other Name: Sugar pill
Active Comparator: Cycloserine Drug: Cycloserine
Oral administration of cycloserine medication (50 mg administered prior to each exposure treatment) on Day 1, 4, 7, and 10 of the study
Other Names:
  • d-cycloserine
  • Seromycin

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Want to participate in a treatment aimed at helping them stop smoking cigarettes
  • Be English-speaking volunteers between 18-55 years of age
  • Meet DSM-IV TR criteria for current nicotine dependence and smoke >10 cigarettes per day for the past year
  • Meet DSM-IV TR criteria for cocaine dependence, but not seeking treatment for cocaine dependence at the time of study
  • Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator

Exclusion Criteria:

  • Meet DSM-IV TR criteria for abuse or dependence on alcohol or other drugs, except for nicotine and cocaine
  • Have psychiatric disorders, such as: current major depression as assessed by SCID; lifetime history of schizophrenia, other psychotic illness, or bipolar illness as assessed by SCID; current organic brain disease or dementia assessed by clinical interview; history of or any current psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of seizure disorder or severe head injury
  • Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
  • Be pregnant or nursing. Female participants must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry and at the end of study participation
  • Have no history of adverse response to d-cycloserine
  • Have any other illness, condition, or use of medications, which in the opinion of the P.I. and/or the admitting physician would preclude safe and/or successful completion of the study
  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: NCT01062932

Locations
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Richard De La Garza, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01062932     History of Changes
Other Study ID Numbers: H-23305, R21DA023588, DPMC
Study First Received: February 3, 2010
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Cycloserine
Nicotine
Smoking

Additional relevant MeSH terms:
Cycloserine
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

ClinicalTrials.gov processed this record on September 18, 2014