Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
25 participants
INTERVENTIONAL
2017-11-29
2024-06-14
Brief Summary
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Detailed Description
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1. Tobacco smokers (n=20) will be imaged with \[11C\]raclopride PET, after overnight abstinence from tobacco. Subjects will smoke their preferred brand of cigarette during the PET scan.
2. Marijuana smokers (n=20) will be imaged with \[11C\]raclopride PET, after overnight abstinence from marijuana. Subjects will smoke a marijuana cigarette during the PET scan.
3. Cocaine users (n=20) will be imaged with \[11C\]raclopride PET, after overnight abstinence from cocaine. Subjects will be administered cocaine during the PET scan.
Aim 2. To examine the magnitude, location and timing of drug-induced beta-endorphin release. \*The Investigators will attempt to use the same subjects from Aim 1 for Aim 2.
1. Tobacco smokers (n=20) will be imaged with \[11C\]carfentanil PET, after overnight abstinence from tobacco. Subjects will smoke their preferred brand of cigarette during the PET scan.
2. Marijuana smokers (n=20) will be imaged with \[11C\]carfentanil PET, after overnight abstinence from marijuana. Subjects will smoke a marijuana cigarette during the PET scan.
3. Cocaine users (n=20) will be imaged with \[11C\]carfentanil PET, after overnight abstinence from cocaine. Subjects will be administered cocaine during the PET scan.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Drug of dependence
There is only one arm to the study. All subjects will receive their drug of dependence in this study. Nicotine dependent subjects will receive tobacco cigarettes, cannabis dependent subjects will receive cannabis cigarettes, and cocaine dependent subjects will receive IV cocaine.
cannabis
All cannabis dependent subjects will use cannabis cigarettes to induce elevated dopamine and beta endorphin levels in the brain.
Interventions
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cannabis
All cannabis dependent subjects will use cannabis cigarettes to induce elevated dopamine and beta endorphin levels in the brain.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able to read and write English and give voluntary written informed consent
3. Not treatment seeking or using treatment medications
Tobacco Smokers
1. Have a Fagerström Test for Nicotine Dependence (FTND) rating of at least 3.
2. Have been using at least 7 cigarettes per day for at least 1 year
3. Carbon monoxide levels \> 10 ppm during intake evaluation
4. Urine cotinine levels of \> 150 ng/mL during intake evaluation
5. Are not current users of marijuana or other illicit drugs
Marijuana Smokers
1. Meet DSM-V criteria for cannabis use disorder based on the structured clinical interview diagnostic (SCID) or regular cannabis use of \>5 times/week
2. Test positive for THC
3. Have been smoking cannabis on a regular basis for \> 1 year
Cocaine Users
1. DSM-V criteria for Cocaine Abuse or Dependence
2. Recent street cocaine use in excess of amounts to be administered in the current study
3. Intravenous and/or smoked (crack/ freebase) use
4. Positive urine toxicology screen for cocaine
Exclusion Criteria
2\. History of or current neurological or significant psychiatric disorder such as schizophrenia or bipolar disorder (DSM-IV Axis 1).
3\. History of significant head trauma. 4. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD).
5\. Regular or current significant use of any prescription, herbal or illegal psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics, ecstasy) in the past 6 mo, with no current illegal drug use confirmed by urine toxicology (except for cocaine and marijuana when relevant).
6\. Significant substance misuse (including alcohol, and excluding cannabis and marijuana when relevant) that in the PI's determination interferes with the study results or safety of the subject.
7\. Have MRI-incompatible implants and other contraindications for MRI, such as a pacemaker, artificial joints, non-removable body piercings, claustrophobia, etc.
8\. Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
9\. Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans.
10\. Subjects with history of IV drug use which would prevent venous access for PET tracer injection.
18 Years
55 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Kelly Cosgrove
Associate Professor
Principal Investigators
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Kelly Cosgrove, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Connecticut Mental Health Center
New Haven, Connecticut, United States
Yale Magnetic Resonance Research Center
New Haven, Connecticut, United States
Yale PET Center
New Haven, Connecticut, United States
Countries
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References
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Calakos KC, Liu H, Lu Y, Anderson JM, Matuskey D, Nabulsi N, Ye Y, Skosnik PD, D'Souza DC, Morris ED, Cosgrove KP, Hillmer AT. Assessment of transient dopamine responses to smoked cannabis. Drug Alcohol Depend. 2021 Oct 1;227:108920. doi: 10.1016/j.drugalcdep.2021.108920. Epub 2021 Jul 29.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1604017594
Identifier Type: -
Identifier Source: org_study_id