Extinction Based Treatment for Nicotine Dependence

NCT00831155 | Completed Phase 1

• 1 other identifier: Pro00009639
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Dependence

Keywords

smoking; nicotine patches; extinction based treatment

Outcome Measures

Primary Outcomes (1)

• To test two quit smoking therapies and to study brain function while each therapy is being used.

  14 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

NO INTERVENTION

Nicotine Replacement Group (NRT): smoke their usual brand of cigarettes up to the quit date.

Interventions

Nicotine Patches, Denicotinized Cigarettes DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Francis J McClernon, Ph.D

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 20, 2015

Record last verified: 2015-04

Locations

US (1)