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Cocaine DependenceEarly Phase 1NCT03349606

Cocaine Use Disorder and Cortical Dopamine

A Early Phase 1 study testing d-amphetamine and [C-11]FLB 457 in people with Cocaine Dependence, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to use [C-11]FLB 457 and amphetamine (oral, 0.5 mg/kg) to measure cortical dopamine transmission in cocaine dependent individuals and healthy controls Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cocaine Dependence
What is being tested?
d-amphetamine and [C-11]FLB 457
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
2 Jun 2010to 1 Jun 2020
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Subjects with Cocaine Dependence INCLUSION CRITERIA

  1. Males or Females 18-40
  2. Fulfill Diagnostic and Statistical Manual (DSM-IV) Diagnosis for Cocaine Dependence
  3. Medically Healthy MAJOR EXCLUSIONS
  4. Major medical, psychiatric, co-morbid drug \& alcohol use disorders 2. Pregnancy or lactation, 3. Contraindications to MRI 4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year 5. Family History of a psychotic illness or manic episode in first-degree relatives

Healthy Subjects INCLUSION CRITERIA

  1. Males or Females 18-40
  2. Absence of present or past psychiatric conditions (including alcohol or drug dependence)
  3. A negative urine drug screen
  4. Medically Healthy

MAJOR EXCLUSIONS

  1. Any medical, psychiatric, co-morbid drug \& alcohol use disorders
  2. Pregnancy or lactation,
  3. Contraindications to MRI
  4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
  5. Family History of a psychotic illness or manic episode, or drug and alcohol Abuse/Dependence in first-degree relatives

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of PIttsburgh PET Facility

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Imaging of Cortical Dopamine Transmission in Cocaine Dependence

The goal of this study is to use [C-11]FLB 457 and amphetamine (oral, 0.5 mg/kg) to measure cortical dopamine transmission in cocaine dependent individuals and healthy controls

Read the detailed description

This study seeks to examine dopamine (DA) transmission in vivo, using positron emission tomography (PET) with [C-11]FLB 457, in cortical regions of interest in subjects who have a history of cocaine dependence. We hypothesize that cocaine dependence is associated with decreases in dopamine in the prefrontal cortical regions compared to controls. This may explain the impulsivity and cognitive deficits that underlie relapse in this disorder.

Being tested
d-amphetamine, [C-11]FLB 457
Medical subject headings
Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • d-amphetamineDrug

    oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain

  • [C-11]FLB 457Radiation

    PET radiotracer

Study groups in NCT03349606
Study groupRoleWhat they receive
Cocaine dependenceExperimental[C-11]FLB 457 PET at baseline and post d-amphetamine
Receives: Drug: d-amphetamine; Radiation: [C-11]FLB 457
ControlsExperimental[C-11]FLB 457 PET at baseline and post d-amphetamine
Receives: Drug: d-amphetamine; Radiation: [C-11]FLB 457

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in Binding potential (BPnd)

    DELTA BPnd

    Measured: Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2017
  2. Study start2 Jun 2010
  3. Primary completion24 Sep 2019
  4. Study completion1 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
\[C-11\]FLB 457 d-amphetamine
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03349606
Sponsor's protocol ID
PRO10030625
Other IDs
R01DA026472, PRO14080588
Status last verified
Jun 2020
First submitted
17 Nov 2017
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing d-amphetamine and [C-11]FLB 457 in people with Cocaine Dependence, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in Binding potential (BPnd) (time frame: Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03349606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

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