RECRUITING

[C-11]NPA PET-amphetamine in Cocaine Use Disorders

Conditions

Cocaine Use Disorder [C-11]NOP-1A, [C-11]NPA , nociceptive opioid peptide receptors, dopamine release

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study uses \[11C\]NPA positron emission tomography (PET) and a d-amphetamine challenge to image amphetamine induced dopamine release in the striatum in subjects with cocaine use disorders (CUD). Amphetamine-induced dopamine release data from this study will be correlated with \[11C\]NOP-1A VT measured at baseline in the midbrain. \[11C\]NOP-1A PET data will be used from aim 1 (see, Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)

Official Title

[C-11]NPA PET-amphetamine in Cocaine Use Disorders (Aim 2)

Quick Facts

Study Start:2021-01-31

Study Completion:2028-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05011760

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Males or females between 18 and 55 years old 2. Fulfil DSM-5 criteria for cocaine use disorder 3. No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,) 4. No current abuse (six months) of opiates, sedative-hypnotics, amphetamines, and MDMA as well as moderate to severe alcohol or cannabis use (twice a week). Nicotine use will be quantified and controlled between groups using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991); 5. Not currently on prescription medical or psychotropic medications 6. No current or past severe medical, endocrine or neurological illnesses including glaucoma, seizure disorders, hypertension, hypercholesterolemia as assessed by a complete medical history and physical 7. Not currently pregnant or breastfeeding 8. No history of significant radioactivity exposure in past year from another research study or occupation that exceeds RDRC guidelines 9. No metallic objects in the body that are contraindicated for MRI 10. No baseline BP ≥ 140/90 and/or HR ≥ 100. 11. No first-degree relative with an MI or stroke prior to middle age 12. No first-degree relative with psychosis or mania. 13. Completed a baseline \[11C\]NOP-1A PET scan in Aim 1 (Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Males or females between 18 and 55 years old
2. Fulfil DSM-5 criteria for cocaine use disorder
3. No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,)
4. No current abuse (six months) of opiates, sedative-hypnotics, amphetamines, and MDMA as well as moderate to severe alcohol or cannabis use (twice a week). Nicotine use will be quantified and controlled between groups using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991);
5. Not currently on prescription medical or psychotropic medications
6. No current or past severe medical, endocrine or neurological illnesses including glaucoma, seizure disorders, hypertension, hypercholesterolemia as assessed by a complete medical history and physical
7. Not currently pregnant or breastfeeding
8. No history of significant radioactivity exposure in past year from another research study or occupation that exceeds RDRC guidelines
9. No metallic objects in the body that are contraindicated for MRI
10. No baseline BP ≥ 140/90 and/or HR ≥ 100.
11. No first-degree relative with an MI or stroke prior to middle age
12. No first-degree relative with psychosis or mania.
13. Completed a baseline \[11C\]NOP-1A PET scan in Aim 1 (Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Rajesh Narendran, MD

CONTACT

4126475176

narendranr@upmc.edu

Principal Investigator

Rajesh Narendran

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of PIttsburgh

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Rajesh Narendran

Rajesh Narendran, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-31

Study Completion Date2028-09-01

Study Record Updates

Study Start Date2021-01-31

Study Completion Date2028-09-01

Terms related to this study

Keywords Provided by Researchers

[C-11]NOP-1A, [C-11]NPA , nociceptive opioid peptide receptors, dopamine release

Additional Relevant MeSH Terms

Cocaine Use Disorder