Cocaine-Related DisordersPhase 2NCT03007394
Lorcaserin in the Treatment of Cocaine Use Disorder
A Phase 2 study testing Lorcaserin in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 12 sites in United States.
Trial summary
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Lorcaserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Dec 2017to 1 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured Clinical Interview for DSM-5
- Is seeking treatment for cocaine use disorder
- Is able to understand and provide written informed consent
- Has used cocaine on at least 1 day in the last 30 days prior to screening
- Has completed all psychological assessments and procedures during the screening period
- If female, not pregnant, lactating, unable to conceive OR must agree to use an acceptable method of birth control
- Has a total body weight greater than 110 pounds and body mass index greater than 20
Who cannot join
- Contact site for more information
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Hassman Research Institute
Berlin, New Jersey, 08009
Boston University School of Medicine
Boston, Massachusetts, 02118-2391
Neuro-Behavioral Clinical Research Inc.
Canton, Ohio, 44718
University of Cincinnati
Cincinnati, Ohio, 45229
Pacific Treatment and Research Center
La Jolla, California, 92307
Meridien Research
Lakeland, Florida, 33805
Altea Research Institute
Las Vegas, Nevada, 89102
Matrix Institute on Addictions
Los Angeles, California, 90016
Pharmacology Research Institute
Newport Beach, California, 92660-2452
Behavioral Clinical Research, Inc.
North Miami, Florida, 33161
CODA, Inc.
Portland, Oregon, 97214
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.
Read the detailed description
This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3 weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week follow-up period, with scheduled visits during Study weeks 14 and 16.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Lorcaserin, Placebo Oral Capsule
- Keywords
- Cocaine Use Disorder
- 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.
LorcaserinDrug
Also called Belviq, lorcaserin hydrochloride
Lorcaserin Capsule
Placebo Oral CapsuleDrug
sugar pill to mimic lorcaserin 10mg capsule
| Study group | Role | What they receive |
|---|---|---|
| Lorcaserin | Active comparator | 10 mg capsule by mouth, twice a day, for 13 weeks Receives: Drug: Lorcaserin |
| Placebo Oral Capsule | Placebo comparator | 10 mg placebo capsule, twice a day, for 13 weeks Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population
Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.
Measured: Treatment weeks 11 - 13
Secondary outcomes (1)
The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence
Measured: Treatment weeks 11-13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start19 Dec 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shwe Gyaw, MD, Study chair, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007394
- Sponsor's protocol ID
- NIDA/VACSP #1033
- Status last verified
- Feb 2020
- First submitted
- 21 Dec 2016
- Last updated
- 5 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT03007394
- Acronym / sponsor ID
- NIDA/VACSP #1033
- Conditions
- Cocaine-Related Disorders
- Keywords
- Cocaine Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 19 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.
Detailed description
This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3 weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week follow-up period, with scheduled visits during Study weeks 14 and 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorcaserin | Active comparator | Drug: Lorcaserin10 mg capsule by mouth, twice a day, for 13 weeks |
| Placebo Oral Capsule | Placebo comparator | Drug: Placebo Oral Capsule10 mg placebo capsule, twice a day, for 13 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured Clinical Interview for DSM-5
- Is seeking treatment for cocaine use disorder
- Is able to understand and provide written informed consent
- Has used cocaine on at least 1 day in the last 30 days prior to screening
- Has completed all psychological assessments and procedures during the screening period
Key exclusion criteria (1 listed)
- Contact site for more information
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 |
|---|---|---|
| LorcaserinAlso: Belviq, lorcaserin hydrochlorideLorcaserin Capsule | Drug | Lorcaserin |
| Placebo Oral Capsulesugar pill to mimic lorcaserin 10mg capsule | Drug | Placebo Oral Capsule |
Primary outcome
The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population
Time frame: Treatment weeks 11 - 13
Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.
1 secondary outcome
The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence
Time frame: Treatment weeks 11-13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shwe Gyaw, MD study chair
National Institute on Drug Abuse (NIDA)
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lorcaserin in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 12 sites 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 7 inclusion and 1 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 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population (time frame: Treatment weeks 11 - 13). 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 5 Aug 2020.