Effects of Smoking on Opioid Receptor Binding: A PET Study

NCT00618631 | Completed Phase 1

• 2 other identifiers: 99990806008-DA-N060
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

Background:

• Tobacco smoking is one of the most preventable causes of morbidity and mortality in the world, but the addictive property of nicotine is such that fewer than 10 percent of people who attempt to quit smoking remain tobacco-free after 1 year. Researchers are studying the addictive properties of nicotine in an attempt to develop more successful medication therapies for smoking cessation.
• Nicotine acts on chemical receptors in the brain, including opioid receptors that affect the perception of pain. Repeated nicotine administration can cause adaptations in the brain s opioid receptors, which heightens the addictive properties of nicotine and increases the likelihood and severity of withdrawal symptoms associated with smoking cessation. Researchers are interested in using positron emission tomography (PET) scanning to study brain chemical responses to nicotine in current smokers and nonsmokers. Objectives:
• To study brain chemical activity related to cigarette smoking and nicotine administration.
• To compare the brain chemical activity of current daily smokers with that of nonsmokers. Eligibility: \- Individuals 21 to 50 years of age who are either current smokers (10 to 25 cigarettes daily for at least 2 years) or have had some exposure to tobacco but have never smoked regularly (may have had a maximum of 20 cigarettes in their lifetime and none in past year). Design:
• Eligible participants will undergo initial medical and psychological screening and neuropsychological testing before beginning the main phase of the study. Participants will be required to abstain from alcohol and drugs (except caffeine, nicotine, and prescription drugs) for 24 hours before each session, and smokers will refrain from smoking after midnight on the night before each session.
• Session 1: Participants will answer questions about nicotine craving and withdrawal symptoms, followed by a magnetic resonance imaging (MRI) scan to provide baseline information about brain activity.
• Session 2 and 3: Participants will answer questions about nicotine craving and withdrawal symptoms, and then will smoke one cigarette (either active nicotine or placebo). Researchers will document participants consumption of the cigarette. After the cigarette is smoked, participants will have a PET scan. Blood samples will be drawn during the PET session.

Conditions

Substance-related Discorder

Keywords

Smoking; Nicotine; Endogenous Opioids; PET Study; Carfentanil

Outcome Measures

Primary Outcomes (1)

• Changes in carfentanil binding.

Secondary Outcomes (1)

• Cardiovascular and subjective responses to smoking one cigarette.

Interventions

Nicotine DRUG

Carfentanil DRUG

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• year old males and females
• smoke 10 cigarettes per day on average for at least 2 years
• urine cotinine level greater than or equal to 200 ng/ml (NicAlert reading greater than or equal to 4)
• estimated IQ score greater than or equal to 85 (competent to give informed consent)
• medically and psychologically healthy as determined by screening criteria.

You may not qualify if:

• interest in reducing or quitting tobacco use
• treatment for nicotine dependence in the past 3 months
• current drug or alcohol abuse or dependence
• consumption of more than 15 alcoholic drinks per week during the past month
• any opiate use in the past 6 months
• marijuana use greater than one time per week on an average during the past month
• other drug use greater than 2 time per month on average during the past 3 months.
• current use of any medication that would interfere with the protocol
• under the influence of a drug or alcohol at experimental sessions
• HIV positive
• history of psychotropic medications
• history of head injury with unconscious longer than 5 minutes
• implantable device or foreign body that would make an MRI examination unobtainable
• MRI abnormality judged clinically significant by the PI
• use of any investigational medication or device within the previous 30 days

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• Johns Hopkins University: collaborator

Study Sites (2)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Medical Institute

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Bencherif B, Guarda AS, Colantuoni C, Ravert HT, Dannals RF, Frost JJ. Regional mu-opioid receptor binding in insular cortex is decreased in bulimia nervosa and correlates inversely with fasting behavior. J Nucl Med. 2005 Aug;46(8):1349-51.

  PMID: 16085593 BACKGROUND

• Champtiaux N, Gotti C, Cordero-Erausquin M, David DJ, Przybylski C, Lena C, Clementi F, Moretti M, Rossi FM, Le Novere N, McIntosh JM, Gardier AM, Changeux JP. Subunit composition of functional nicotinic receptors in dopaminergic neurons investigated with knock-out mice. J Neurosci. 2003 Aug 27;23(21):7820-9. doi: 10.1523/JNEUROSCI.23-21-07820.2003.

  PMID: 12944511 BACKGROUND

MeSH Terms

Conditions

Smoking

Interventions

Nicotine; carfentanil

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Stephen J Heishman, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2008
• First Posted: February 20, 2008
• Study Start: January 17, 2008
• Study Completion: January 8, 2015
• Last Updated: April 5, 2018

Record last verified: 2015-01-08

Locations

US (2)