Drug AbusePhase 1NCT00828659
Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users
A Phase 1 study testing Active Comparator #1, Active Comparator #2 and Active Comparator #3 in people with Drug Abuse and Healthy, run by Eisai Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse, Healthy
- What is being tested?
- Active Comparator #1, Active Comparator #2 and Active Comparator #3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Apr 2009
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects 18 to 55 years of age, inclusive.
- Body mass index (BMI) within the range of 18 to 33 kg/m2, inclusive, and a minimum weight of at least 50 kg at Screening.
- Free from any clinically significant medical or psychiatric abnormality
- Recreational polydrug user with a history of psychedelic and depressant drug use,and at least one occasion of use in the past 3 months.
- Female subjects must have a negative serum pregnancy test at Screening and urine pregnancy test at each admission.
- Female subjects of childbearing potential must be practising abstinence or using and willing to continue using a medically acceptable form of birth control for at least 1 month after the last study drug administration. Male subjects who have female partners of childbearing potential must ensure that their partner use an acceptable method of contraception.
- Willingness to take a drug that might alter perception in a controlled setting.
Who cannot join
- A subject will not be considered eligible to participate in this study, if any one of the following exclusion criteria is satisfied:
- A history or presence of drug or alcohol dependence (excluding nicotine and caffeine).
- Use of non-prescription, prescription medication or natural health products (except acetaminophen, vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 7 days prior to first drug administration in the qualification phase and throughout the study.
- Use of SSRIs (e.g. fluoxetine, paroxetine, citalopram) within 14 days prior to first drug administration in the qualification phase and throughout the study.
- History of allergy or hypersensitivity to the study drugs
- Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration
- Treatment with any investigational drug within 30 days prior to first drug administration during the qualification phase.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users
The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users.
- Conditions
- Drug Abuse, Healthy
- Being tested
- Placebo, Active Comparator #1, Active Comparator #2, Active Comparator #3, Lorcaserin Dose #1
- Keywords
- Abuse potential
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Active Comparator #1Drug
Active Comparator #2Drug
Active Comparator #3Drug
Lorcaserin Dose #1Drug
Lorcaserin Dose #2Drug
Lorcaserin Dose #3Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Active Comparator #1 | Active comparator | Not described Receives: Drug: Active Comparator #1 |
| Active Comparator #2 | Active comparator | Not described Receives: Drug: Active Comparator #2 |
| Active Comparator #3 | Active comparator | Not described Receives: Drug: Active Comparator #3 |
| Lorcaserin Dose #1 | Experimental | Not described Receives: Drug: Lorcaserin Dose #1 |
| Lorcaserin Dose #2 | Experimental | Not described Receives: Drug: Lorcaserin Dose #2 |
| Lorcaserin Dose #3 | Experimental | Not described Receives: Drug: Lorcaserin Dose #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the abuse potential of lorcaserin
Secondary outcomes (1)
To evaluate the safety and tolerability of lorcaserin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828659
- Sponsor's protocol ID
- APD356-013
- Status last verified
- Jul 2009
- First submitted
- 22 Jan 2009
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Shram MJ, Schoedel KA, Bartlett C, Shazer RL, Anderson CM, Sellers EM. Evaluation of the abuse potential of lorcaserin, a serotonin 2C (5-HT2C) receptor agonist, in recreational polydrug users. Clin Pharmacol Ther. 2011 May;89(5):683-92. doi: 10.1038/clpt.2011.20. Epub 2011 Mar 16.
PubMed 21412231
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Crossover Study to Evaluate the Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users
- ClinicalTrials.gov ID
- NCT00828659
- Acronym / sponsor ID
- APD356-013
- Conditions
- Drug Abuse, Healthy
- Keywords
- Abuse potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 26 Jan 2009 (estimated)
- 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 this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Active Comparator #1 | Active comparator | Drug: Active Comparator #1 |
| Active Comparator #2 | Active comparator | Drug: Active Comparator #2 |
| Active Comparator #3 | Active comparator | Drug: Active Comparator #3 |
| Lorcaserin Dose #1 | Experimental | Drug: Lorcaserin Dose #1 |
| Lorcaserin Dose #2 | Experimental | Drug: Lorcaserin Dose #2 |
| Lorcaserin Dose #3 | Experimental | Drug: Lorcaserin Dose #3 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female subjects 18 to 55 years of age, inclusive.
- Body mass index (BMI) within the range of 18 to 33 kg/m2, inclusive, and a minimum weight of at least 50 kg at Screening.
- Free from any clinically significant medical or psychiatric abnormality
- Recreational polydrug user with a history of psychedelic and depressant drug use,and at least one occasion of use in the past 3 months.
- Female subjects must have a negative serum pregnancy test at Screening and urine pregnancy test at each admission.
Key exclusion criteria (7 listed)
- A subject will not be considered eligible to participate in this study, if any one of the following exclusion criteria is satisfied:
- A history or presence of drug or alcohol dependence (excluding nicotine and caffeine).
- Use of non-prescription, prescription medication or natural health products (except acetaminophen, vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 7 days prior to first drug administration in the qualification phase and throughout the study.
- Use of SSRIs (e.g. fluoxetine, paroxetine, citalopram) within 14 days prior to first drug administration in the qualification phase and throughout the study.
- History of allergy or hypersensitivity to the study drugs
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| Active Comparator #1 | Drug | Active Comparator #1 |
| Active Comparator #2 | Drug | Active Comparator #2 |
| Active Comparator #3 | Drug | Active Comparator #3 |
| Lorcaserin Dose #1 | Drug | Lorcaserin Dose #1 |
| Lorcaserin Dose #2 | Drug | Lorcaserin Dose #2 |
| Lorcaserin Dose #3 | Drug | Lorcaserin Dose #3 |
Primary outcome
To evaluate the abuse potential of lorcaserin
1 secondary outcome
To evaluate the safety and tolerability of lorcaserin
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 12 Sep 2019.
- Derived from this study: PubMed 21412231Shram MJ, Schoedel KA, Bartlett C, Shazer RL, Anderson CM, Sellers EM. Evaluation of the abuse potential of lorcaserin, a serotonin 2C (5-HT2C) receptor agonist, in recreational polydrug users. Clin Pharmacol Ther. 2011 May;89(5):683-92. doi: 10.1038/clpt.2011.20. Epub 2011 Mar 16.
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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 Phase 1 study testing Active Comparator #1, Active Comparator #2 and Active Comparator #3 in people with Drug Abuse and Healthy, run by Eisai Inc. at 1 site in Canada.
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 7 inclusion and 7 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 12 Sep 2019. 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 Canada. 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 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?
To evaluate the abuse potential of lorcaserin. 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 NCT00828659, which also lists 1 linked publication.
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 12 Sep 2019.