Cocaine-Related DisordersEarly Phase 1MHPNCT03606473
Brain Mechanisms in Young Adults
A Early Phase 1 study testing d-amphetamine and [C-11]NPA in people with Cocaine-Related Disorders, run by Gale Richardson at 1 site in United States.
Trial summary
The goal of this study is to use [C-11]NPA and amphetamine (oral, 0.5 mg/kg) to measure striatal dopamine transmission in prenatal cocaine exposed subjects (PCE) and comparison subjects (COMP) Read more about this study
- Who is it for?
- Ages 25 to 30 years
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- d-amphetamine and [C-11]NPA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2018to 31 Aug 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 25 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prenatal cocaine exposed subjects (PCE): Offspring exposed to prenatal cocaine (concurrent exposure to prenatal alcohol and tobacco are not exclusionary) as determined by detailed interviewing during pregnancy
- Comparison group (COMP): Offspring NOT exposed to prenatal cocaine (exposure to prenatal alcohol and tobacco are not exclusionary) as determined by detailed interviewing during pregnancy.
Who cannot join
- No current mania or psychosis based on current mental status exam and SCID-IV modules A (pages A18-A37) and B (pages B1-B8);
- No current cocaine, heroin, opioid, methadone, benzodiazepine, methamphetamine use (negative urine drug screen at both day of screening and the day of PET scan);
- No current use of cannabis (a negative urine drug screen on day of PET scan; Note: a positive cannabis urine on the day of screening will not be exclusionary because cannabis tends to be used for recreation; and it takes a long time for it turn negative because it is released from fat cells in body long after subject has quit; and it has been shown to not impact amphetamine-induced dopamine release in prior studies);
- Not currently taking prescription or over the counter medications that can alter monoamine transmission in the brain or interact with the d-amphetamine challenge or alter amphetamine concentrations (major CYP2D6 inhibitors such as fluoxetine, thioridazine, terbinafine etc., as well as pseudo-ephedrine, atomoxetine, SSRIs, etc.);
- No use of acidifying (fruit juice; beverages; ascorbic acid) and alkalinizing agents (such as sodium bicarbonate) that alter amphetamine concentrations at least 12 hrs before PET scan day;
- No current or past severe medical or neurological illnesses such as seizure disorders, head injury with prolonged loss of consciousness, hypertension, prior MI, CAD etc., (determined by physician investigator's elicited medical history, physical exam, review of labs, and EKG results);
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- Not currently pregnant (serum pregnancy test at screening) or breastfeeding;
- No history of radioactivity exposure via prior nuclear medicine studies or occupational exposure in past 12 months;
- No metallic objects in the body that are contraindicated for MRI;
- SBP > 135, DBP > 85, and/or HR ≤ 50 or ≥ 100 (documented before the PET scans; Note: it is not unusual to have to repeat screening vital signs in subjects' because some subjects tend to have white coat syndrome and present with elevated vitals at screening, which later normalizes);
- No first-degree relative with an MI or stroke or TIA prior to 50 years of age;
- No first-degree relative with psychosis or mania.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Exploration of Mechanisms of Effects of Prenatal Cocaine Exposure in Young Adults
The goal of this study is to use [C-11]NPA and amphetamine (oral, 0.5 mg/kg) to measure striatal dopamine transmission in prenatal cocaine exposed subjects (PCE) and comparison subjects (COMP)
Read the detailed description
Prenatal cocaine exposure (PCE) has consistently been associated with behavioral deficits through childhood, adolescence, and young adulthood in our ongoing study (PRO15080516 - Effects of Prenatal Cocaine Use: 25-Year Follow-Up). Further, 21-year-olds with PCE in our study were twice as likely to have been arrested as non-exposed offspring, were more likely to be diagnosed with Conduct Disorder, had higher disinhibition scores, were significantly more likely to use alcohol and marijuana earlier, and to have earlier sexual intercourse. The effects of PCE on the developing nervous system may cause changes in brain function that underlie these behavioral outcomes.
This study seeks to examine dopamine (DA) transmission in vivo, using positron emission tomography (PET) with [C-11]NPA, in striatal regions of interest in subjects who have a history of exposure to prenatal cocaine (PCE). We hypothesize that PCE is associated with increases in dopamine in the striatum relative to COMP. This may explain the impulsivity and high risk behaviors in PCE subjects
- Conditions
- Cocaine-Related Disorders
- Being tested
- d-amphetamine, [C-11]NPA
- Keywords
- prenatal exposure
- 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
is used to stimulate dopamine release in the brain
[C-11]NPARadiation
PET radiotracer
| Study group | Role | What they receive |
|---|---|---|
| Prenatal cocaine exposed subjects | Experimental | [C-11]NPA PET at baseline and post d-amphetamine Receives: Drug: d-amphetamine; Radiation: [C-11]NPA |
| Comparison subjects | Experimental | [C-11]NPA PET at baseline and post d-amphetamine Receives: Drug: d-amphetamine; Radiation: [C-11]NPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted30 Jul 2018
- Study start24 Jan 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- \[C-11\]NPA d-amphetamine
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gale Richardson
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Gale Richardson, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606473
- Sponsor's protocol ID
- PRO17080203
- Acronym
- MHP
- Status last verified
- Sep 2020
- First submitted
- 20 Jul 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Mechanisms of Effects of Prenatal Cocaine Exposure in Young Adults
- ClinicalTrials.gov ID
- NCT03606473
- Acronym / sponsor ID
- MHP / PRO17080203
- Conditions
- Cocaine-Related Disorders
- Keywords
- prenatal exposure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Gale RichardsonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to use [C-11]NPA and amphetamine (oral, 0.5 mg/kg) to measure striatal dopamine transmission in prenatal cocaine exposed subjects (PCE) and comparison subjects (COMP)
Detailed description
Prenatal cocaine exposure (PCE) has consistently been associated with behavioral deficits through childhood, adolescence, and young adulthood in our ongoing study (PRO15080516 - Effects of Prenatal Cocaine Use: 25-Year Follow-Up). Further, 21-year-olds with PCE in our study were twice as likely to have been arrested as non-exposed offspring, were more likely to be diagnosed with Conduct Disorder, had higher disinhibition scores, were significantly more likely to use alcohol and marijuana earlier, and to have earlier sexual intercourse. The effects of PCE on the developing nervous system may cause changes in brain function that underlie these behavioral outcomes.
This study seeks to examine dopamine (DA) transmission in vivo, using positron emission tomography (PET) with [C-11]NPA, in striatal regions of interest in subjects who have a history of exposure to prenatal cocaine (PCE). We hypothesize that PCE is associated with increases in dopamine in the striatum relative to COMP. This may explain the impulsivity and high risk behaviors in PCE subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- [C-11]NPA d-amphetamine
| Arm | Type | Receives |
|---|---|---|
| Prenatal cocaine exposed subjects | Experimental | Drug: d-amphetamine, Radiation: [C-11]NPA[C-11]NPA PET at baseline and post d-amphetamine |
| Comparison subjects | Experimental | Drug: d-amphetamine, Radiation: [C-11]NPA[C-11]NPA PET at baseline and post d-amphetamine |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Prenatal cocaine exposed subjects (PCE): Offspring exposed to prenatal cocaine (concurrent exposure to prenatal alcohol and tobacco are not exclusionary) as determined by detailed interviewing during pregnancy
- Comparison group (COMP): Offspring NOT exposed to prenatal cocaine (exposure to prenatal alcohol and tobacco are not exclusionary) as determined by detailed interviewing during pregnancy.
Key exclusion criteria (12 listed)
- No current mania or psychosis based on current mental status exam and SCID-IV modules A (pages A18-A37) and B (pages B1-B8);
- No current cocaine, heroin, opioid, methadone, benzodiazepine, methamphetamine use (negative urine drug screen at both day of screening and the day of PET scan);
- No current use of cannabis (a negative urine drug screen on day of PET scan; Note: a positive cannabis urine on the day of screening will not be exclusionary because cannabis tends to be used for recreation; and it takes a long time for it turn negative because it is released from fat cells in body long after subject has quit; and it has been shown to not impact amphetamine-induced dopamine release in prior studies);
- Not currently taking prescription or over the counter medications that can alter monoamine transmission in the brain or interact with the d-amphetamine challenge or alter amphetamine concentrations (major CYP2D6 inhibitors such as fluoxetine, thioridazine, terbinafine etc., as well as pseudo-ephedrine, atomoxetine, SSRIs, etc.);
- No use of acidifying (fruit juice; beverages; ascorbic acid) and alkalinizing agents (such as sodium bicarbonate) that alter amphetamine concentrations at least 12 hrs before PET scan day;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| d-amphetamineis used to stimulate dopamine release in the brain | Drug | Comparison subjects, Prenatal cocaine exposed subjects |
| [C-11]NPAPET radiotracer | Radiation | Comparison subjects, Prenatal cocaine exposed subjects |
Primary outcome
Percent change in Binding potential (BPnd)
Time frame: Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours
DELTA BPND
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing d-amphetamine and [C-11]NPA in people with Cocaine-Related Disorders, run by Gale Richardson 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?
The sponsor lists 2 inclusion and 12 exclusion criteria. 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 3 Sep 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?
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 3 Sep 2020.