Extinction Based Treatment for Nicotine Dependence (Extinction01)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Duke University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Duke University
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00831155
First received: January 27, 2009
Last updated: November 6, 2009
Last verified: November 2009
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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).
| Condition | Intervention |
|---|---|
|
Nicotine Dependence |
Drug: Nicotine Patches, Denicotinized Cigarettes |
| 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:
MedlinePlus related topics:
Smoking
Drug Information available for:
Nicotine polacrilex
U.S. FDA Resources
Further study details as provided by Duke University:
Primary Outcome Measures:
- To test two quit smoking therapies and to study brain function chile each therapy is being used. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | January 2012 (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 deniconized 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:
- 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831155
Contacts
| Contact: Matt Hallyburton, BA | 919-684-9593 | matt.hallyburton@duke.edu |
| Contact: Joseph McClernon, Ph.D | 919-668-3987 | mccle011@mc.duke.edu |
Locations
| United States, North Carolina | |
| Duke Medical Center | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Avery Lutz, BA 919-684-9587 lutz0011@mc.duke.edu | |
Sponsors and Collaborators
Duke University
Investigators
| Principal Investigator: | Francis J McClernon, Ph.D | Duke University |
More Information
No publications provided
| Responsible Party: | F. Joseph McClernon, Ph.D, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00831155 History of Changes |
| Other Study ID Numbers: | Pro00009639 |
| Study First Received: | January 27, 2009 |
| Last Updated: | November 6, 2009 |
| 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 Substance-Related Disorders Mental Disorders Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 18, 2012
