ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 153 for:    cannabis | Recruiting, Enrolling by invitation Studies

Imaging the Neurochemistry of Drug Addiction With PET

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cannabis Drug: cannabis Early Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Imaging the Neurochemistry of Drug Addiction With PET
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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.
Drug: cannabis
All cannabis dependent subjects will use cannabis cigarettes to induce elevated dopamine and beta endorphin levels in the brain.
Other Name: marijuana




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817698


Contacts
Contact: Kelly Cosgrove, PhD 203-737-6969 kelly.cosgrove@yale.edu
Contact: Jon Mikael Anderson, MSc 203-737-7074 jonmikael.anderson@yale.edu

Locations
United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: JonMikael Anderson    203-737-7074    jonmikael.anderson@yale.edu   
Yale Magnetic Resonance Research Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: JonMikael Anderson    203-737-7074    jonmikael.anderson@yale.edu   
Yale PET Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: JonMikael Anderson    203-737-7074    jonmikael.anderson@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kelly Cosgrove, PhD Yale University

Responsible Party: Kelly Cosgrove, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT02817698     History of Changes
Other Study ID Numbers: 1604017594
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kelly Cosgrove, Yale University:
smoking
cannabis
cocaine

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders