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Effects of Smoking on Opioid Receptor Binding Using [(11)C]Carfentanil: an Imaging PET Study
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), October 2008
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00618631
  Purpose

Objective: To determine whether nicotine, at the dose delivered through a cigarette (1-2 mg), will increase the release of endogenous opioids, measured by the displacement of the mu-opioid PET receptor radioligand [(11)C]carfentanil and to determine whether smokers have adaptations in the opioid system compared with nonsmokers.

Study Population: 20 current, daily smoikers and 20 never-smokers who have smoked between 1 and 20 cigarettes in their lifetime.

Design: Double-blind, placebo-controlled, parallel groups design.

Outcome Measures: 1) displacement [(11)C]carfentanil binding, secondary to the release of endorphins by nicotine; 2) upregulation of [(11)C]carfentanil specific binding in smokers compared with nonsmokers; 3) [(11)C]carfentanil specific binding as a function of the mu-opioid receptor A118G polymorphism; and 4) correlation between self-report measures of nicotine effect and [(11)C]carfentanil binding profile.


Condition Intervention
Substance-Related Discorder
Drug: Nicotine
Drug: Carfentanil

MedlinePlus related topics: Smoking
Drug Information available for: Nicotine polacrilex Nicotine tartrate Carfentanil Carfentanil citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title: Effects of Smoking on Opioid Receptor Binding Using [(11)C]Carfentanil: an Imaging PET Study

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Changes in carfentanil binding.

Secondary Outcome Measures:
  • Cardiovascular and subjective responses to smoking one cigarette.

Estimated Enrollment: 40
Study Start Date: January 2008
Intervention Details:
    Drug: Nicotine
    N/A
    Drug: Carfentanil
    N/A
Detailed Description:

Objective: To determine whether nicotine, at the dose delivered through a cigarette (1-2 mg), will increase the release of endogenous opioids, measured by the displacement of the mu-opioid PET receptor radioligand [(11)C]carfentanil and to determine whether smokers have adaptations in the opioid system compared with nonsmokers.

Study Population: 20 current, daily smoikers and 20 never-smokers who have smoked between 1 and 20 cigarettes in their lifetime.

Design: Double-blind, placebo-controlled, parallel groups design.

Outcome Measures: 1) displacement [(11)C]carfentanil binding, secondary to the release of endorphins by nicotine; 2) upregulation of [(11)C]carfentanil specific binding in smokers compared with nonsmokers; 3) [(11)C]carfentanil specific binding as a function of the mu-opioid receptor A118G polymorphism; and 4) correlation between self-report measures of nicotine effect and [(11)C]carfentanil binding profile.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA FOR SMOKERS:

    1. 21-40 year old males
    2. smoke 10-25 cigarettes per day on average for at least 2 years
    3. urine cotinine level greater than or equal to 200 ng/ml (NicAlert reading greater than or equal to 4)
    4. estimated IQ score greater than or equal to 85 (competent to give informed consent)
    5. medically and psychologically healthy as determined by screening criteria.

EXCLUSION CRITERIA FOR SMOKERS:

  1. interest in reducing or quitting tobacco use
  2. treatment for nicotine dependence in the past 3 months
  3. history of drug or alcohol dependence
  4. consumption of more than 15 alcoholic drinks per week during the past month
  5. use of any illicit drug during the past 6 months
  6. current use of any medication that would interfere with the protocol
  7. under the influence of a drug or alcohol at experimental sessions
  8. HIV positive
  9. history of psychotropic medications
  10. history of head injury with unconscious longer than 5 minutes
  11. implantable device or foreign body that would make an MRI examination unobtainable
  12. MRI abnormality judged clinically significant by the PI
  13. use of any investigational medication or device within the previous 30 days
  14. donation at least 450 ml of blood or equivalent levels of plasma within the previous 30 days
  15. exposure to ionizing radiation that, in combination with the study tracer, would result in a cumulative exposure exceeding 5 rem in one calendar year
  16. any subject judged by the PI to be inappropriate for the study.
  17. chronic pulmonary disease, including COPD, bronchitis, asthma, and emphysema

INCLUSION CRITERIA FOR NONSMOKERS:

  1. 21-40 year old males
  2. smoked 1-20 cigarettes in their life and none in past year
  3. urine cotinine level less than 30 ng/ml (NicAlert reading less than or equal to 1)
  4. estimated IQ score greater than or equal to 85 (competent to give informed consent)
  5. medically and psychologically healthy as determined by screening criteria.

EXCLUSION CRITERIA FOR NONSMOKERS:

  1. use of any tobacco products in the past year
  2. history of drug or alcohol dependence
  3. consumption of more than 15 alcoholic drinks per week during the past month
  4. use of any illicit drug during the past 6 months
  5. current use of any medication that would interfere with the protocol
  6. under the influence of a drug or alcohol at experimental sessions
  7. HIV positive
  8. history of psychotropic medications
  9. history of head injury with unconscious longer than 5 minutes
  10. implantable device or foreign body that would make an MRI examination unobtainable
  11. MRI abnormality judged clinically significant by the PI
  12. use of any investigational medication or device within the previous 30 days
  13. donation of at least 450 ml of blood or equivalent levels of plasma within the previous 30 days
  14. exposure to ionizing radiation that, in combination with the study tracer, would result in a cumulative exposure exceeding 5 rem in one calendar year
  15. any subject judged by the PI to be inappropriate for the study.
  16. chronic pulmonary disease, including COPD, bronchitis, asthma, and emphysema
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618631

Contacts
Contact: Rebecca Evans (410) 550-1570 evansre@intra.nida.nih.gov

Locations
United States, Maryland
National Institute on Drug Abuse Recruiting
Baltimore, Maryland, United States, 21224
Johns Hopkins Medical Institute Recruiting
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 999908060, 08-DA-N060
Study First Received: February 17, 2008
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00618631  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Smoking
Nicotine
Endogenous Opioids
PET Study
Carfentanil
Smoking
Nicotine

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Nicotine
Carfentanil

Additional relevant MeSH terms:
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Depressants
Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009