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

ConditionCocaine Use Disorder

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorRajesh Narendran

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females between 18 and 55 years old

Fulfil DSM-5 criteria for cocaine use disorder

No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,)

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);

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Baseline [C-11]NPA PET Scan
Radiation
Radiotracer
d-amphetamine
Drug
Oral, 0.5 mg/Kg
Post-amphetamine [C-11]NPA PET Scan
Radiation
Radiotracer

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: PETExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

DELTA binding potential relative to non displaceable uptake (BPND)

DELTA BPND is the change in BPND from the baseline PET scan to post-amphetamine PET scan that will be acquired 2.5 to 3 hours after d-amphetamine administration (0.5 mg/Kg, oral)

Time frame

Baseline, and 2.5 to 3 hours post-amphetamine

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rajesh Narendran

Lead sponsor

University of Pittsburgh

Sponsor institution

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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