Effects of Nicotine Replacement Therapy and D-cycloserine on Nicotine Treatment Seekers
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 55 |
| Updated: | 4/2/2016 |
| Start Date: | August 2013 |
The investigators previously developed a cigarette cue extinction treatment (CET) procedure
in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue
Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that
triggers it. This is accomplished through repeated exposure to that trigger, while removing
the patient's ability to act out the conditioned response. In the present study, the trigger
is a lit cigarette, and the response the investigators seek to un-pair is cigarette craving.
In the procedure the investigators have previously developed and intend to use again, the
participant is shown a pack of his brand of choice cigarettes. The researcher removes a
cigarette from the pack, lights it, and asks the participant to hold the cigarette without
smoking it for 90 seconds. This procedure is repeated seven times over the course of a
six-hour lab session. The investigators hope to boost the clinical response to smoking cue
exposure therapy in quitters on NRT (nicotine replacement therapy) pretreatment by
pharmacological augmentation with the partial NMDA receptor agonist D-cycloserine (DCS).
Behavioral extinction training is a form of learning that may be modulated by NMDA receptor
mediated glutamate transmission. The study's main hypothesis is that the partial NMDA
receptor agonist D-cycloserine (DCS) facilitates cue exposure training and may prevent
relapse to smoking. The aim of the proposed study is to assess whether DCS-facilitation of
cue-exposure therapy improves abstinence among smokers on the nicotine patch seeking
treatment. Development of an effective treatment strategy to enhance the effectiveness of
NRTs would have a direct and significant positive impact on public health.
in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue
Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that
triggers it. This is accomplished through repeated exposure to that trigger, while removing
the patient's ability to act out the conditioned response. In the present study, the trigger
is a lit cigarette, and the response the investigators seek to un-pair is cigarette craving.
In the procedure the investigators have previously developed and intend to use again, the
participant is shown a pack of his brand of choice cigarettes. The researcher removes a
cigarette from the pack, lights it, and asks the participant to hold the cigarette without
smoking it for 90 seconds. This procedure is repeated seven times over the course of a
six-hour lab session. The investigators hope to boost the clinical response to smoking cue
exposure therapy in quitters on NRT (nicotine replacement therapy) pretreatment by
pharmacological augmentation with the partial NMDA receptor agonist D-cycloserine (DCS).
Behavioral extinction training is a form of learning that may be modulated by NMDA receptor
mediated glutamate transmission. The study's main hypothesis is that the partial NMDA
receptor agonist D-cycloserine (DCS) facilitates cue exposure training and may prevent
relapse to smoking. The aim of the proposed study is to assess whether DCS-facilitation of
cue-exposure therapy improves abstinence among smokers on the nicotine patch seeking
treatment. Development of an effective treatment strategy to enhance the effectiveness of
NRTs would have a direct and significant positive impact on public health.
Inclusion Criteria:
1. Seeking treatment for nicotine dependence
2. Medically healthy on the basis of physical examination and medical history, vital
signs, EKG, and laboratory tests, with a negative pregnancy test for females.
3. A DSM-IV diagnosis of nicotine dependence with physiological dependence. Has smoked
at least 15 cigarettes daily for at least two years.
4. Able to perform study procedures.
5. Males or females between the ages of 21-55 yrs.
6. Female Participants agree to use an effective method of birth control
Exclusion Criteria:
1. A DSM-IV diagnosis of lifetime history of abuse or dependence on alcohol or drugs
other than nicotine
2. Current Axis I diagnosis or current treatment with psychotropic medications (within
last three months).
3. Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or
anxiety disorders.
4. Participants on parole or probation
5. History of significant recent violent behavior, e.g., one or more incidents of
violent behavior in the past year resulting in physical damage.
6. Unstable medical condition, Blood pressure > 140/90, Pregnancy.
7. History of allergic reaction to nicotine patch.
8. History of hypersensitivity to cycloserine.
9. Any history of seizures
10. History of renal disease.
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New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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