Cognitive Remediation With D-Cycloserine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01399866
First received: July 19, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60 to a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion criteria, and demonstrate response to cue reactivity at the screening visit, will either be:

  • started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which method to use to quit smoking will be based on participant choice as well as taking into account any medical contraindications to either therapy.
  • evaluated to confirm abstinence from smoking. Recently abstinent participants referred by a smoking cessation clinic, PCP or self referred must have an expired air CO < 10 ppm to confirm abstinence.

Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study medication and cue exposure treatment, spaced five to nine days apart. Subjects will complete 2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire study involves twelve visits and will last approximately ten weeks. For recently abstinent participants referred by a smoking cessation clinic, PCP or self referred, the study involves 7 visits (screening and baseline visit will be merged into one and there is no CBT component) and will last approximately 7 weeks.


Condition Intervention Phase
Smoking Cessation
Drug: D-cycloserine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Cognitive Remediation With D-cycloserine to Improve Smoking Cessation Outcomes

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Effect of D-cycloserine + cue-exposure treatment on continuous abstinence from tobacco smoking. [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Participants assigned to receive D-cycloserine + CET will achieve better maintenance of tobacco abstinence, as assessed with self-report and saliva cotinine measurements, than those who receive placebo + CET at week 6 follow up visits


Secondary Outcome Measures:
  • Effect of D-cycloserine + cue-exposure treatment on skin conductance [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (skin conductance) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.

  • Effect of D-cycloserine + cue-exposure treatment on heart rate [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (heart rate) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.

  • Effect of D-cycloserine + cue-exposure treatment on electromyogram [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (electromyogram) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.

  • Effect of D-cycloserine + cue-exposure treatment on craving [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Recently abstinent smokers assigned to receive D-cycloserine + CET will have less craving at the Post-Extinction Assessment than those who receive placebo + CET

  • Effect of D-cycloserine + cue-exposure treatment on attentional bias toward smoking cues [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Recently abstinent smokers assigned to receive D-cycloserine + CET will have less attentional bias (Smoking Stroop task) toward smoking cues at the Post-Extinction Assessment than those who receive placebo + CET


Enrollment: 150
Study Start Date: May 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
50 mg capsule,single dose, twice, one week apart, by mouth
Drug: Placebo
Active Comparator: D-cycloserine
50 mg capsule,single dose, twice, one week apart, by mouth
Drug: D-cycloserine
2 single weekly doses, 50 mg capsule

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must have smoked an average of ≥ 10 cigarettes/day during the past 6 months
  • have expired air CO ≥ 10 ppm or urine cotinine ≥ 100 ng/mL
  • meet DSM-IV criteria for nicotine dependence
  • aged 18 - 65
  • Recently abstinent participants referred by a PCP, smoking cessation clinic or self referred must have an expired air CO < 10 ppm to confirm abstinence

Exclusion Criteria:

  • Severe or uncontrolled medical or psychiatric illness
  • History of multiple hospitalizations within the last six months for an ongoing medical condition
  • Any significant, current and unstable cardiovascular disease, end stage renal failure, severe COPD requiring oxygen, any current unstable neurological disease, a history of seizures or epilepsy, or a history of head trauma with lasting neurological sequelae, will be excluded for their safety.
  • Major depressive episode, mania or mixed episode in the prior 6 months
  • Lifetime history of psychosis, delusional disorder, organic mental disorder by DSM-IV criteria, or ongoing cognitive impairment will also be excluded for their safety,
  • Current excessive use of alcohol (>21 drinks/week in female subjects; >28 drinks/week in male subjects)
  • Current use of illicit drugs.
  • Current steroid use, current, daily use of benzodiazepines, or participants who are unwilling to modify their benzodiazepine use will.
  • Pregnant or breastfeeding women will be excluded, as well as women of childbearing potential who will not use a medically acceptable method of contraception (i.e. IUD, oral contraceptives).
  • Participants who are deaf, blind, or experience any other significant sensory impairment that would preclude them from completing study procedures will also be excluded, as well as participants who are unable to understand study procedures or provide informed consent.
  • Participants receiving isoniazid or ethionamide, or who have a known sensitivity to D-cycloserine.
  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: NCT01399866

Locations
United States, Massachusetts
Massachusetts General Hospital - Center For Addiction Medicine
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: A. Eden Evins, MD, MPH Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: A. Eden Evins, Director Center for Addiction Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01399866     History of Changes
Other Study ID Numbers: 2011P000411
Study First Received: July 19, 2011
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
D-cycloserine
Smoking cues
Cognitive remediation
physiologic reactivity
craving

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 August 20, 2014