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Extinction Based Treatment for Nicotine Dependence (Extinction01)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00831155
First received: January 27, 2009
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to test two quit smoking therapies and to study brain function while each therapy is being used. You will be randomly assigned (like flipping a coin) to one of the two groups. The first therapy is Extinction-Based therapy (EBT). If you are in this group, you will switch to smoking denicotinized cigarettes while wearing a 21 mg/d nicotine patch for one month prior to your quit date. The second therapy is a standard Nicotine Replacement therapy (NRT). If you are in this group, you will smoke your usual brand of cigarettes up to the quit date. Following the quit date, both groups will undergo standard nicotine replacement therapy (21 mg/d for 6 weeks; 14 mg/d for 2 weeks, 7 mg/d for 2 weeks).

In addition to the above, we will recruit a sample of former smokers who are now regular users of e-cigarettes. This group [ECIG] will undergo the same screening and baseline assessments as the EBT and NRT groups up to the completion of fMRI1.


Condition Intervention Phase
Nicotine Dependence
Drug: Nicotine Patches, Denicotinized Cigarettes
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brain Substrates of Extinction Based Treatment for Nicotine Dependence

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To test two quit smoking therapies and to study brain function while each therapy is being used. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: January 2009
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Extinction Based Group (EBT): switch to smoking denicotinized cigarettes while wearing a 21mg/day nicotine patch for one month prior to their quit date.
Drug: Nicotine Patches, Denicotinized Cigarettes
Both groups will receive standard Nicotine Replacement Therapy after the quit date. The Extinction Based group will receive Nicotine patches and denicotinized cigarettes before their quit date
No Intervention: 2
Nicotine Replacement Group (NRT): smoke their usual brand of cigarettes up to the quit date.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (conventional cigarette smokers):

  • generally healthy,
  • between the ages of 18 and 55,
  • smoking of at least 10 cigarettes/day of a brand delivering >0.5mg nicotine according to the standard Federal Trade Commission (FTC) method,
  • an afternoon expired CO concentration of at least 10 ppm (to confirm inhalation),
  • an interest in quitting smoking
  • right-handed

Inclusion Criteria (e-cigarette smokers):

  • generally healthy,
  • between the ages of 18 and 55,
  • prior history of smoking of at least 10 conventional cigarettes/day for at least two years of a brand delivering >0.5mg nicotine according to the standard Federal Trade Commission (FTC) method,
  • no smoking of conventional cigarettes in the last 6 months;
  • daily use of a nicotine-containing e-cigarette for at least 3 months;
  • taking of at least 100 puffs per day from a nicotine-containing e-cigarette;
  • an afternoon expired CO concentration <5 ppm (to confirm they are not combustible cigarette users);
  • nicotine test strip reading >3
  • right-handed

Exclusion Criteria:

  • inability to attend all required experimental sessions,
  • significant health problems (e.g., chronic hypertension (BP>150/90 sitting after 10 minutes), emphysema, seizure disorder, history of significant heart problems),
  • use of psychoactive medications,
  • use of smokeless tobacco,
  • liver or kidney disorder (except kidney stones, gallstones)
  • lung disorder (including but not limited to COPD, emphysema, and asthma)
  • report of coronary heart disease; heart attack; cardiac rhythm disorder (irregular heart rhythm; chest pains; cardiac disorder (including but not limited to valvular heart disease, heart murmur, heart failure)
  • current alcohol or drug abuse,
  • use of illegal drugs as measured by urine drug screen,
  • current use of nicotine replacement therapy or other smoking cessation treatment,
  • presence of conditions that would make MRI unsafe (e.g., pacemaker, metal objects in the body, IUD, orthopedic pins or screws, etc.), or
  • presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies or disorders).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831155

Locations
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Francis J McClernon, Ph.D Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00831155     History of Changes
Other Study ID Numbers: Pro00009639
Study First Received: January 27, 2009
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
smoking
nicotine patches
extinction based treatment

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014