Cognitive Remediation With D-Cycloserine
This study is currently recruiting participants.
Verified July 2011 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01399866
First received: July 19, 2011
Last updated: July 21, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
One hundred 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 physiologic reactivity (skin conductance, Heart rate, electromyogram), attentional bias and craving in response to smoking cues [ Time Frame: It will be measured once during the study, at visit 11 (study week 10) after two sessions of cue exposure treatment ] [ Designated as safety issue: No ]Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (heart rate, skin conductance and EMG) reactivity to smoking cues, less craving and less attentional bias (Smoking Stroop task) toward smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo | Drug: Placebo |
| Active Comparator: D-cycloserine |
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 year
- 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 causing loss of consciousness for at least one minute, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399866
Contacts
| Contact: Heather Burrell, BA | 617-643-4691 | hburrell@partners.org |
| Contact: Gladys Pachas, MD | 617-643-1991 | gpachas1@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital - Center For Addiction Medicine | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Heather Burrell, BA 617-643-4691 hburrell@partners.org | |
| Sub-Investigator: Gladys N Pachas, MD | |
| Sub-Investigator: Michael Otto, PhD | |
| Sub-Investigator: Corinne Cather, PhD | |
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, MD, MPH/ 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: | July 21, 2011 |
| 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:
|
Smoking Habits 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 May 16, 2013