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Imaging the Neurochemistry of Drug Addiction With PET

Primary Purpose

Smoking, Cannabis

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

cannabis

About this trial

This is an interventional other trial for Smoking focused on measuring smoking, cannabis, cocaine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Have a Fagerström Test for Nicotine Dependence (FTND) rating of at least 3.
Have been using at least 7 cigarettes per day for at least 1 year
Carbon monoxide levels > 10 ppm during intake evaluation
Urine cotinine levels of > 150 ng/mL during intake evaluation
Are not current users of marijuana or other illicit drugs

Marijuana Smokers

Meet DSM-V criteria for cannabis use disorder based on the structured clinical interview diagnostic (SCID) or regular cannabis use of >5 times/week
Test positive for THC
Have been smoking cannabis on a regular basis for > 1 year

Cocaine Users

DSM-V criteria for Cocaine Abuse or Dependence
Recent street cocaine use in excess of amounts to be administered in the current study
Intravenous and/or smoked (crack/ freebase) use
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.

Sites / Locations

Connecticut Mental Health CenterRecruiting
Yale Magnetic Resonance Research CenterRecruiting
Yale PET CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug of dependence

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in dopamine levels at baseline and after drug of dependence administration as confirmed by PET images.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02817698

First Posted

June 27, 2016

Last Updated

October 12, 2023

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT02817698

Brief Title

Imaging the Neurochemistry of Drug Addiction With PET

Official Title

Imaging the Neurochemistry of Drug Addiction With PET

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 29, 2017 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking, Cannabis

Keywords

smoking, cannabis, cocaine

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug of dependence

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

cannabis

Other Intervention Name(s)

marijuana

Intervention Description

All cannabis dependent subjects will use cannabis cigarettes to induce elevated dopamine and beta endorphin levels in the brain.

Primary Outcome Measure Information:

Title

Change in dopamine levels at baseline and after drug of dependence administration as confirmed by PET images.

Description

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.

Time Frame

90 minute PET scan acquisition. Drug of dependence will be given at -35 mins

Title

Change in beta endorphin levels at baseline and after drug of dependence administration as confirmed by PET images.

Description

Time Frame

120 minute PET scan acquisition. Drug of dependence will be given at -35 mins

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: General Inclusion Criteria: Men and women, aged 18-55 years Able to read and write English and give voluntary written informed consent Not treatment seeking or using treatment medications Tobacco Smokers Have a Fagerström Test for Nicotine Dependence (FTND) rating of at least 3. Have been using at least 7 cigarettes per day for at least 1 year Carbon monoxide levels > 10 ppm during intake evaluation Urine cotinine levels of > 150 ng/mL during intake evaluation Are not current users of marijuana or other illicit drugs Marijuana Smokers Meet DSM-V criteria for cannabis use disorder based on the structured clinical interview diagnostic (SCID) or regular cannabis use of >5 times/week Test positive for THC Have been smoking cannabis on a regular basis for > 1 year Cocaine Users DSM-V criteria for Cocaine Abuse or Dependence Recent street cocaine use in excess of amounts to be administered in the current study Intravenous and/or smoked (crack/ freebase) use 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kelly Cosgrove, PhD

Phone

203-737-6969

kelly.cosgrove@yale.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Marc Grasso, BA

Phone

203-737-7074

marc.grasso@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelly Cosgrove, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Connecticut Mental Health Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Grasso

Phone

203-737-7074

marc.grasso@yale.edu

Facility Name

Yale Magnetic Resonance Research Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Grasso

Phone

203-737-7074

marc.grasso@yale.edu

Facility Name

Yale PET Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Grasso

Phone

203-737-7074

marc.grasso@yale.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34399137

Citation

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.

Results Reference

derived

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Imaging the Neurochemistry of Drug Addiction With PET

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