Status:
COMPLETED
Cognitive Remediation With D-Cycloserine
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 relap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01399866
Start Date
May 1 2011
End Date
October 1 2013
Last Update
September 26 2018
Active Locations (1)
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1
Massachusetts General Hospital - Center For Addiction Medicine
Boston, Massachusetts, United States, 02114