Cocaine-Related DisordersPhase 1NCT03143543
Phase I Functional Magnetic Resonance Imaging (fMRI) Pharmacodynamic Studies of Compounds for Opioid Use Disorder and Cocaine Use Disorder
A Phase 1 study testing Group A Lorcaserin (10mg) and Group A2 Lorcaserin (20 mg) in people with Cocaine-Related Disorders and Opioid-Related Disorders, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of Project 2 is to execute phase I functional magnetic resonance imaging (fMRI) studies to assess the effects of lorcaserin on brain target engagement (measured by fMRI brain activation and neural connectivity) in cocaine use disorder (CocUD) subjects and/or opioid use disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine-Related Disorders, Opioid-Related Disorders
- What is being tested?
- Group A Lorcaserin (10mg) and Group A2 Lorcaserin (20 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 6 Dec 2019
- Phase
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females treatment-seeking cocaine and/or opioid users between 18 and 55 years of age
- Understand the study procedures and provide written informed consent
- Must be in residential treatment for substance use disorder
- Meet current DSM-5 criteria for Cocaine Use Disorder with moderate or severe severity, and current DSM-IV diagnosis of Cocaine Dependence or Abuse, and/or current DSM-5 criteria for Opioid Use Disorder with moderate or severe severity, and/or current DSM-IV diagnosis of Opioid Dpendence or Abuse.
- Have been abstinent from cocaine and/or opioid use for at least 1 week
- Have vital signs as follows: resting pulse between 55 and 95 bpm, blood pressures between 90-139 mm Hg systolic and 50-89 mm Hg diastolic
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- Have hematology and chemistry laboratory tests that are within normal limits, except that liver function tests must be less than twice the upper limit of normal and judged by the study physician to be clinically insignificant.
- Have a normal baseline ECG as shown by normal sinus rhythm with the exception of sinus arrhythmia or mild sinus bradycardia (heart rate 50-59 beats per minute), and with normal conduction (including normal QTcF) with the exception of early repolarization judged to be clinically insignificant by both the study physician and the study cardiologist.
- For adults who ar 20 years old or older, have a Body Mass Index (BMI) that is 18.5 or greater according to the CDC Calculator for Adults.. For adolescents who are 18 or 19 years old, BMI that is fifth percentile or greater according to the CDC Calculator for Children and Teens.
- Have no contraindications for study participation as determined by history and physical examination
- Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory and fMRI testing
- No pregnant or nursing women will be permitted in the study, and women must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device with spermicide, or condoms). Men will be advised to use condoms. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and at the end of study participation.
Who cannot join
- Have concurrent DSM-IV diagnosis of any psychoactive substance use dependence other than cocaine, nicotine, marijuana, or opioid dependence.
- Have a DSM-5 axis I psychiatric disorder, other than substance use disorder, including by not limited to Bipolar Disorder, Major Depressive Disorder, ADHD, or Schizophrenia, or a neurological disorder requiring ongoing treatment and/or making study participation unsafe.
- Subjects with evidence or history of any clinically significant medical disorder including cardiovascular, pulmonary, CNS, hepatic, or renal, except that controlled hypertension, controlled hypothyroidism, and cancer in remission will not be excluded.
- Subjects who have Type 1 or Type 2 diabetes mellitus, since weight loss may increase the risk of hypoglycemia in patients with Type 2 diabetes mellitus treated with insulin secretagogues (eg., sulfonylureas), and lorcaserin has not been studied in combination with insulin.
- Subjects with an abnormal QTcF on ECG
- Have a history of seizures (excluding childhood febrile seizures), or loss of consciousness for more than 20 minutes
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- Have significant current suicidal or homicidal ideation or a suicide attempt within the past 6 months
- Be HIV positive by self-report or history
- Be pregnant or nursing or not using a reliable form of contraception if able to conceive. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and at the end of study participation
- Have an other illness or condition, which in the opinion of the PI would preclude safe and/or successful completion of the study.
- Be using any medications or drugs that can affect the central nervous system other than cocaine, marijuana, alcohol, caffeine, and nicotine.
- Be using any medication (including over-the-counter medication or food suplements) that may interact adversely with lorcaserin, including other serotonergic drugs, including SNRIs and SSRIs, triptans, drugs that impair metabolism of serotonin (including MAOIs), dietary supplements such as St. John's wort and tryptophan, tramadol, or antipsychotics or other dopamine antagonists.. See Lorcaserin Drug Interactions table (attached) for detailed list of these medications.
- Prior to starting study medication, and prior to each MRI scanning session, have positive breath alcohol level, or have a positive urine drug screen for any drug of abuse other than marijuana.
- Have metal fragments or other bodily metal (e.g., pacemaker), or significant claustrophobia that would put the subjects at risk for MRI scanning.
- Subjects who are allergic to lorcaserin
- Subjects who have taken any investigational drug within 90 days prior to baseline.
- Subjects who are taking opioids for medical reasons (e.g., cancer, injuries, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of Project 2 is to execute phase I functional magnetic resonance imaging (fMRI) studies to assess the effects of lorcaserin on brain target engagement (measured by fMRI brain activation and neural connectivity) in cocaine use disorder (CocUD) subjects and/or opioid use disorder.
Read the detailed description
During the screening period (Study Days -3 and -2), the urine drug screen (UDS) must be negative for cocaine and opioids, and the self-reported last use of cocaine or opioids must be at least seven days prior to this result, in order to ensure that possible cocaine or opioid withdrawal has ended. After these criteria have been met, all subjects will receive placebo at 8:30 AM for one day during the Placebo Pretreatment Baseline Day (Study Day -1). The first fMRI session (fMRI #1) will take place at 10:00 AM on the following day (Study Day 1). Following fMRI #1, the subjects will be randomized into two parallel groups (Group A: Lorcaserin; Group B: Parallel Placebo). Based on the information that a lower dose of lorcaserin has the potential to be clinically effective , and based on the safety and abuse potential data from human studies, as well as the preclinical data on interaction with cocaine , the study will begin with the lower dose of lorcaserin (10 mg per day). For Group A (lorcaserin group), the lorcaserin dose will be 10 mg orally per day for 7 days. For Group B (parallel placebo group), identical appearing placebo will be given orally according to the same schedule as lorcaserin for 7 days. After the 7 days of treatment with study medications, fMRI #2 will take place, then study medications will be discontinued. A follow-up visit will occur one week after the last dose of study medication. See Section II.b for details and criteria for stopping or continuing this dosage based on the results of the interim analysis, which will take place after 15 subjects have completed at each arm. Based on the interim analysis, if there is no significant effect and no trend towards significant effect (p > 0.10) for the lower dose lorcaserin in the primary regions of interest for the cue-reactivity fMRI task, and no significant accumulation of adverse effects, then testing will stop for the lower dose of lorcaserin, and testing will begin for the higher dose of lorcaserin (10 mg twice per day) 7 days. The higher dose of lorcaserin will be tested in a two group parallel arm design, initially with 15 subjects in the high dose lorcaserin arm and 15 subjects in the parallel placebo arm. Another interim analysis will take place after 15 subjects have completed at each arm in the higher dose lorcaserin study.
- Being tested
- Group A Lorcaserin (10mg), Group A2 Lorcaserin (20 mg), Group B Parallel Placebo, Group B2 Parallel Placebo
- Keywords
- cocaine disorder, opioid disorder, lorcaserin, MRI, fMRI
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A Lorcaserin (10mg)Drug
Also called Belviq
10 mg lorcaserin orally for 7 days
Group A2 Lorcaserin (20 mg)Drug
Also called Belviq
20 mg lorcaserin orally for 7 days
Group B Parallel PlaceboOther
Oral placebo vs 10 mg lorcaserin
Group B2 Parallel PlaceboOther
Oral placebo vs 20 mg lorcaserin
| Study group | Role | What they receive |
|---|---|---|
| Group A Lorcaserin (10mg) | Experimental | 10 mg lorcaserin orally for 7 days Receives: Drug: Group A Lorcaserin (10mg) |
| Group B Parallel Placebo | Placebo comparator | Placebo orally for 7 days vs Group A Receives: Other: Group B Parallel Placebo |
| Group A2 Lorcaserin (20 mg) | Experimental | 20 mg lorcaserin orally for 7 days Receives: Drug: Group A2 Lorcaserin (20 mg) |
| Group B2Parallel Placebo | Placebo comparator | Placebo orally for 7 days vs Group A2 Receives: Other: Group B2 Parallel Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target engagement by lorcaserin
To determine target engagement by lorcaserin in a cocaine-Stroop and/or opioid-Stroop cue-reactivity fMRI task in cocaine use disorder (CocUD) and/or Opioid Use Disorder Subjects
Measured: Seven Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startJul 2015
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Why it stopped: FDA removal of drug from the market due to cancer risks
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.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Starting lorcaserin dosage of 10 mg per day for 7 days in one arm, versus placebo for 7 days in parallel arm. An interim analysis will take place after 15 subjects have completed at each arm. Based on the interim analysis, if there is no significant effect and no trend towards significance for the lower dose of lorcaserin in the primary regions of interest for fMRI task, and no significant accumulation of adverse effects, testing will stop for the lower dose of lorcaserin, and testing will begin for the higher dose, which is the FDA approved usual dose for lorcaserin (20 mg per day, given as 10 mg twice per day). The higher dose of lorcaserin will be tested in a two group parallel arm design, initially with 15 subjects in lorcaserin arm and 15 subjects in the parallel placebo arm. Another interim analysis will take place after 15 subjects have completed at each arm in the higher dose lorcaserin study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- James Bjork, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143543
- Sponsor's protocol ID
- HM20003329
- Other IDs
- 5U54DA038999-04
- Status last verified
- Jul 2019
- First submitted
- 6 Jan 2016
- Last updated
- 27 Apr 2020
- Results posted
- 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 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Functional Magnetic Resonance Imaging (fMRI) Pharmacodynamic Studies of Compounds for Opioid Use Disorder and Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT03143543
- Acronym / sponsor ID
- HM20003329
- Keywords
- cocaine disorder, opioid disorder, lorcaserin, MRI, fMRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA removal of drug from the market due to cancer risks
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2015 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 8 May 2017 (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 purpose of Project 2 is to execute phase I functional magnetic resonance imaging (fMRI) studies to assess the effects of lorcaserin on brain target engagement (measured by fMRI brain activation and neural connectivity) in cocaine use disorder (CocUD) subjects and/or opioid use disorder.
Detailed description
During the screening period (Study Days -3 and -2), the urine drug screen (UDS) must be negative for cocaine and opioids, and the self-reported last use of cocaine or opioids must be at least seven days prior to this result, in order to ensure that possible cocaine or opioid withdrawal has ended. After these criteria have been met, all subjects will receive placebo at 8:30 AM for one day during the Placebo Pretreatment Baseline Day (Study Day -1). The first fMRI session (fMRI #1) will take place at 10:00 AM on the following day (Study Day 1). Following fMRI #1, the subjects will be randomized into two parallel groups (Group A: Lorcaserin; Group B: Parallel Placebo). Based on the information that a lower dose of lorcaserin has the potential to be clinically effective , and based on the safety and abuse potential data from human studies, as well as the preclinical data on interaction with cocaine , the study will begin with the lower dose of lorcaserin (10 mg per day). For Group A (lorcaserin group), the lorcaserin dose will be 10 mg orally per day for 7 days. For Group B (parallel placebo group), identical appearing placebo will be given orally according to the same schedule as lorcaserin for 7 days. After the 7 days of treatment with study medications, fMRI #2 will take place, then study medications will be discontinued. A follow-up visit will occur one week after the last dose of study medication. See Section II.b for details and criteria for stopping or continuing this dosage based on the results of the interim analysis, which will take place after 15 subjects have completed at each arm. Based on the interim analysis, if there is no significant effect and no trend towards significant effect (p > 0.10) for the lower dose lorcaserin in the primary regions of interest for the cue-reactivity fMRI task, and no significant accumulation of adverse effects, then testing will stop for the lower dose of lorcaserin, and testing will begin for the higher dose of lorcaserin (10 mg twice per day) 7 days. The higher dose of lorcaserin will be tested in a two group parallel arm design, initially with 15 subjects in the high dose lorcaserin arm and 15 subjects in the parallel placebo arm. Another interim analysis will take place after 15 subjects have completed at each arm in the higher dose lorcaserin study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Starting lorcaserin dosage of 10 mg per day for 7 days in one arm, versus placebo for 7 days in parallel arm. An interim analysis will take place after 15 subjects have completed at each arm. Based on the interim analysis, if there is no significant effect and no trend towards significance for the lower dose of lorcaserin in the primary regions of interest for fMRI task, and no significant accumulation of adverse effects, testing will stop for the lower dose of lorcaserin, and testing will begin for the higher dose, which is the FDA approved usual dose for lorcaserin (20 mg per day, given as 10 mg twice per day). The higher dose of lorcaserin will be tested in a two group parallel arm design, initially with 15 subjects in lorcaserin arm and 15 subjects in the parallel placebo arm. Another interim analysis will take place after 15 subjects have completed at each arm in the higher dose lorcaserin study.
| Arm | Type | Receives |
|---|---|---|
| Group A Lorcaserin (10mg) | Experimental | Drug: Group A Lorcaserin (10mg)10 mg lorcaserin orally for 7 days |
| Group B Parallel Placebo | Placebo comparator | Other: Group B Parallel PlaceboPlacebo orally for 7 days vs Group A |
| Group A2 Lorcaserin (20 mg) | Experimental | Drug: Group A2 Lorcaserin (20 mg)20 mg lorcaserin orally for 7 days |
| Group B2Parallel Placebo | Placebo comparator | Other: Group B2 Parallel PlaceboPlacebo orally for 7 days vs Group A2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Males and females treatment-seeking cocaine and/or opioid users between 18 and 55 years of age
- Understand the study procedures and provide written informed consent
- Must be in residential treatment for substance use disorder
- Meet current DSM-5 criteria for Cocaine Use Disorder with moderate or severe severity, and current DSM-IV diagnosis of Cocaine Dependence or Abuse, and/or current DSM-5 criteria for Opioid Use Disorder with moderate or severe severity, and/or current DSM-IV diagnosis of Opioid Dpendence or Abuse.
- Have been abstinent from cocaine and/or opioid use for at least 1 week
Key exclusion criteria (17 listed)
- Have concurrent DSM-IV diagnosis of any psychoactive substance use dependence other than cocaine, nicotine, marijuana, or opioid dependence.
- Have a DSM-5 axis I psychiatric disorder, other than substance use disorder, including by not limited to Bipolar Disorder, Major Depressive Disorder, ADHD, or Schizophrenia, or a neurological disorder requiring ongoing treatment and/or making study participation unsafe.
- Subjects with evidence or history of any clinically significant medical disorder including cardiovascular, pulmonary, CNS, hepatic, or renal, except that controlled hypertension, controlled hypothyroidism, and cancer in remission will not be excluded.
- Subjects who have Type 1 or Type 2 diabetes mellitus, since weight loss may increase the risk of hypoglycemia in patients with Type 2 diabetes mellitus treated with insulin secretagogues (eg., sulfonylureas), and lorcaserin has not been studied in combination with insulin.
- Subjects with an abnormal QTcF on ECG
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 |
|---|---|---|
| Group A Lorcaserin (10mg)Also: Belviq10 mg lorcaserin orally for 7 days | Drug | Group A Lorcaserin (10mg) |
| Group A2 Lorcaserin (20 mg)Also: Belviq20 mg lorcaserin orally for 7 days | Drug | Group A2 Lorcaserin (20 mg) |
| Group B Parallel PlaceboOral placebo vs 10 mg lorcaserin | Other | Group B Parallel Placebo |
| Group B2 Parallel PlaceboOral placebo vs 20 mg lorcaserin | Other | Group B2Parallel Placebo |
Primary outcome
Target engagement by lorcaserin
Time frame: Seven Days
To determine target engagement by lorcaserin in a cocaine-Stroop and/or opioid-Stroop cue-reactivity fMRI task in cocaine use disorder (CocUD) and/or Opioid Use Disorder Subjects
Results and safety
The study was stopped early (reason given: FDA removal of drug from the market due to cancer risks). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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.
James Bjork, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group A Lorcaserin (10mg) and Group A2 Lorcaserin (20 mg) in people with Cocaine-Related Disorders and Opioid-Related Disorders, run by Virginia Commonwealth University 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 12 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 Apr 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: FDA removal of drug from the market due to cancer risks). Results are not available in the source record.
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?
Target engagement by lorcaserin (time frame: Seven Days). 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 27 Apr 2020.