Trial Outcomes & Findings for Imaging the Neurochemistry of Drug Addiction With PET (NCT NCT02817698)

NCT ID: NCT02817698

Last Updated: 2024-12-12

Results Overview

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. Baseline levels will be assessed during the first scan in the morning after overnight abstinence from their drug of dependence using a 90-minute PET acquisition. Then, drug of dependence will be administered 35 minutes before a second 90-minute PET acquisition. The beginning of the second PET scan will be approximately 5 hours after the beginning of the first PET scan, however in some cases this may be longer, or the scans may take place on separate days due to scheduling constraints or scan cancellations.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 25 participants
• Primary outcome timeframe: 90 minute PET scan acquisition. Drug of dependence will be given at -35 mins
• Results posted on: 2024-12-12

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging the Neurochemistry of Drug Addiction With PET

Baseline characteristics by cohort

Measure	Drug of Dependence n=25 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29.52 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

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

Population: Subjects were analyzed based on cluster size with a threshold of 16 voxels.

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. Baseline levels will be assessed during the first scan in the morning after overnight abstinence from their drug of dependence using a 90-minute PET acquisition. Then, drug of dependence will be administered 35 minutes before a second 90-minute PET acquisition. The beginning of the second PET scan will be approximately 5 hours after the beginning of the first PET scan, however in some cases this may be longer, or the scans may take place on separate days due to scheduling constraints or scan cancellations.

Outcome measures

Measure	Drug of Dependence n=12 Participants 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.
Change in Dopamine Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. R VS	0.0388 mm^3 Interval 0.022 to 0.058
Change in Dopamine Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. R Putamen	0.033 mm^3 Interval 0.028 to 0.038
Change in Dopamine Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. R Caudate	0.0285 mm^3 Interval 0.027 to 0.03
Change in Dopamine Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. L VS	0.0368 mm^3 Interval 0.025 to 0.052
Change in Dopamine Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. L Caudate	0.038 mm^3 Interval 0.035 to 0.041
Change in Dopamine Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. R VS/Caudate	0.035 mm^3 Interval 0.035 to 0.035
Change in Dopamine Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. L Putamen	0.037 mm^3 Interval 0.022 to 0.052

PRIMARY outcome

Timeframe: 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. Baseline levels will be assessed during the first scan in the morning after 12 hour abstinence from their drug of dependence using a 90-minute PET acquisition. Then, drug of dependence will be administered 35 minutes before a second 90-minute PET acquisition. The beginning of the second PET scan will be approximately 5 hours after the beginning of the first PET scan, however in some cases this may be longer, or the scans may take place on separate days due to scheduling constraints or scan cancellations.

Outcome measures

Measure	Drug of Dependence n=8 Participants 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.
Change in Beta Endorphin Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. Front	-0.0068 mm^3 Interval -0.0501 to 0.0237
Change in Beta Endorphin Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. Amygdala	0.0190 mm^3 Interval -0.2803 to 0.349
Change in Beta Endorphin Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. Thalamus	0.0146 mm^3 Interval -0.0355 to 0.0748
Change in Beta Endorphin Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. Caudate	0.0082 mm^3 Interval -0.1278 to 0.131
Change in Beta Endorphin Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. Putamen	0.0100 mm^3 Interval -0.0342 to 0.0865
Change in Beta Endorphin Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. Cingulum	0.0233 mm^3 Interval -0.0687 to 0.0909
Change in Beta Endorphin Levels at Baseline and After Drug of Dependence Administration as Confirmed by PET Images. Insula	0.0153 mm^3 Interval -0.0432 to 0.091

Adverse Events

Drug of Dependence

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Drug of Dependence n=25 participants at risk 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.

General disorders Anxiety/Tachycardia

4.0% 1/25 • Number of events 1 • 5 years

Additional Information

Marc Grasso

Yale University

Phone: 2037377074

Email: marc.grasso@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place