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

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ClinicalTrials.gov Identifier: NCT01907594
Recruitment Status : Unknown
Verified July 2013 by S. Rob Vorel, New York State Psychiatric Institute.
Recruitment status was:  Not yet recruiting
First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
S. Rob Vorel, New York State Psychiatric Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Drug: D-cycloserine Drug: Nicotine Replacement Therapy (patch) Behavioral: Smoking Cue Exposure Behavioral: Progressive Muscle Relaxation Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of Nicotine Replacement Therapy and D-cycloserine on Nicotine Treatment Seekers
Study Start Date : August 2013
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Active Comparator: D-cycloserine
The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.
Drug: D-cycloserine
Drug: Nicotine Replacement Therapy (patch)
Behavioral: Smoking Cue Exposure
Behavioral: Progressive Muscle Relaxation
Placebo Comparator: Gelatin Capsule
The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.
Drug: Nicotine Replacement Therapy (patch)
Behavioral: Smoking Cue Exposure
Behavioral: Progressive Muscle Relaxation
Drug: Placebo
The investigators will administer Gelatin Capsule instead of D-Cycloserine in a double blind fashion to some of study subjects.




Primary Outcome Measures :
  1. Number of Cigarettes Smoked [ Time Frame: 3 months ]
    Smoking Diary kept of daily cigarette smoking.



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907594


Locations
United States, New York
New York State Psychiatric Institute Not yet recruiting
New York, New York, United States, 10032
Contact: S. Rob Vorel, MD PHD    212-543-5669      
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: S. Rob Vorel, MD, PhD New York State Psychiatric Institute

Responsible Party: S. Rob Vorel, Principal Investigator, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01907594     History of Changes
Other Study ID Numbers: 6769
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Nicotine
Cycloserine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites