Effects of Nicotine Replacement Therapy and D-cycloserine on Nicotine Treatment Seekers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cigarette Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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D-cycloserine

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

Group Type ACTIVE_COMPARATOR

D-cycloserine

Intervention Type DRUG

Nicotine Replacement Therapy (patch)

Intervention Type DRUG

Smoking Cue Exposure

Intervention Type BEHAVIORAL

Progressive Muscle Relaxation

Intervention Type BEHAVIORAL

Gelatin Capsule

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

Group Type PLACEBO_COMPARATOR

Nicotine Replacement Therapy (patch)

Intervention Type DRUG

Smoking Cue Exposure

Intervention Type BEHAVIORAL

Progressive Muscle Relaxation

Intervention Type BEHAVIORAL

Placebo

Intervention Type DRUG

The investigators will administer Gelatin Capsule instead of D-Cycloserine in a double blind fashion to some of study subjects.

Interventions

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D-cycloserine

Intervention Type DRUG

Nicotine Replacement Therapy (patch)

Intervention Type DRUG

Smoking Cue Exposure

Intervention Type BEHAVIORAL

Progressive Muscle Relaxation

Intervention Type BEHAVIORAL

Placebo

The investigators will administer Gelatin Capsule instead of D-Cycloserine in a double blind fashion to some of study subjects.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes