Status:
COMPLETED
Effects of Smoking on Opioid Receptor Binding: A PET Study
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Substance-related Discorder
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
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 at...
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 recepto...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA FOR SMOKERS:
- 21-50 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.
- EXCLUSION CRITERIA FOR SMOKERS:
- 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
- donation at least 450 ml of blood or equivalent levels of plasma within the previous 30 days
- exposure to ionizing radiation that, in combination with the study tracer, would result in a cumulative exposure exceeding 5 rem in one calendar year
- any subject judged by the PI to be inappropriate for the study.
- chronic pulmonary disease, including COPD, bronchitis, asthma, and emphysema
- pregnant, nursing, or become pregnant during the study
- INCLUSION CRITERIA FOR NONSMOKERS:
- 21-50 year old males and females
- smoked 1-20 cigarettes in their life and none in past year
- urine cotinine level less than 30 ng/ml (NicAlert reading less than or equal to 1)
- estimated IQ score greater than or equal to 85 (competent to give informed consent)
- medically and psychologically healthy as determined by screening criteria.
- EXCLUSION CRITERIA FOR NONSMOKERS:
- use of any tobacco products in the past year
- 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 average during past month
- other drug use greater than two times per month on average during past three 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
- donation of at least 450 ml of blood or equivalent levels of plasma within the previous 30 days
- exposure to ionizing radiation that, in combination with the study tracer, would result in a cumulative exposure exceeding 5 rem in one calendar year
- any subject judged by the PI to be inappropriate for the study.
- chronic pulmonary disease, including COPD, bronchitis, asthma, and emphysema
- pregnant, nursing, or become pregnant during the study
Exclusion
Key Trial Info
Start Date :
January 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00618631
Start Date
January 17 2008
End Date
January 8 2015
Last Update
April 5 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224
2
Johns Hopkins Medical Institute
Baltimore, Maryland, United States, 21287