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Trial record 39 of 151 for:    cannabis | Recruiting, Enrolling by invitation Studies

Imaging the Neurochemistry of Drug Addiction With PET

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ClinicalTrials.gov Identifier: NCT02817698
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Kelly Cosgrove, Yale University

June 27, 2016
June 29, 2016
March 15, 2018
November 29, 2017
September 2021   (Final data collection date for primary outcome measure)
  • Change in dopamine levels at baseline and after drug of dependence administration as confirmed by PET images. [ Time Frame: 90 minute PET scan acquisition. Drug of dependence will be given at -35 mins ]
    PET images will be obtained in dependent subjects at baseline and after drug of dependence administration. Change in DA levels will be determined by change in binding potential of raclopride.
  • Change in beta endorphin levels at baseline and after drug of dependence administration as confirmed by PET images. [ Time Frame: 120 minute PET scan acquisition. Drug of dependence will be given at -35 mins ]
    PET images will be obtained in dependent subjects at baseline and after drug of dependence administration. Change in beta endorphin levels will be determined by change in binding potential of carfentanil.
Same as current
Complete list of historical versions of study NCT02817698 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Imaging the Neurochemistry of Drug Addiction With PET
Imaging the Neurochemistry of Drug Addiction With PET
The investigators' project has two overarching goals. 1) The investigators will use newly developed positron emission tomography (PET) technology to investigate the dopaminergic neurochemistry of drugs of abuse including marijuana, traditional cigarettes, and cocaine, and 2) The investigators will extend PET technology to an additional neurotransmitter system - namely, the opioid-ergic system, using the same drugs of abuse.

Aim 1. To examine the magnitude, location and timing of drug-induced dopamine release.

  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.
Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Smoking
  • Cannabis
Drug: cannabis
All cannabis dependent subjects will use cannabis cigarettes to induce elevated dopamine and beta endorphin levels in the brain.
Other Name: marijuana
Experimental: 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.
Intervention: Drug: cannabis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Same as current
September 2021
September 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • General Inclusion Criteria:

    1. Men and women, aged 18-55 years
    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:

  • 1. Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology.

    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.

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact: Kelly Cosgrove, PhD 203-737-6969 kelly.cosgrove@yale.edu
Contact: Jon Mikael Anderson, MSc 203-737-7074 jonmikael.anderson@yale.edu
United States
 
 
NCT02817698
1604017594
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Kelly Cosgrove, Yale University
Yale University
Not Provided
Principal Investigator: Kelly Cosgrove, PhD Yale University
Yale University
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP