Cocaine Use DisorderPhase 1BED IN 31NCT02522325
Reinforcing Effects of Cocaine During Phendimetrazine Maintenance
A Phase 1 study testing Phendimetrazine and Cocaine in people with Cocaine Use Disorder, run by William Stoops at 1 site in United States.
Trial summary
This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Phendimetrazine and Cocaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2018
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recent cocaine use
Who cannot join
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to cocaine or phendimetrazine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Department of Behavioral Science
Lexington, Kentucky, 40536-0086
About this study
Official title: Behavioral Effects of Drugs (Inpatient): 31 (Cocaine and Phendimetrazine)
This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.
- Conditions
- Cocaine Use Disorder
- Being tested
- Phendimetrazine, Cocaine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhendimetrazineDrug
Also called Bontril
Phendimetrazine will be administered in divided doses twice daily.
CocaineDrug
Intranasal cocaine will be administered during experimental sessions.
PlaceboDrug
Placebo capsules will contain only cornstarch.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will be maintained on oral placebo, administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. Receives: Drug: Cocaine; Drug: Placebo |
| Phendimetrazine | Experimental | Subjects will be maintained on oral phendimetrazine (up to 210 mg/day) administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. Receives: Drug: Phendimetrazine; Drug: Cocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 10 choices between a portion of each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both phendimetrazine and placebo maintenance.
Measured: After at least seven days of maintenance placebo or target phendimetrazine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2018
- Study completionDec 2018
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 Use DisorderStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Stoops
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, William Stoops, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522325
- Sponsor's protocol ID
- 15-0553
- Other IDs
- R01DA036553
- Acronym
- BED IN 31
- Status last verified
- Jun 2019
- First submitted
- 10 Aug 2015
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Effects of Drugs (Inpatient): 31 (Cocaine and Phendimetrazine)
- ClinicalTrials.gov ID
- NCT02522325
- Acronym / sponsor ID
- BED IN 31 / 15-0553
- Conditions
- Cocaine Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- William StoopsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Cocaine, Drug: PlaceboSubjects will be maintained on oral placebo, administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
| Phendimetrazine | Experimental | Drug: Phendimetrazine, Drug: CocaineSubjects will be maintained on oral phendimetrazine (up to 210 mg/day) administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recent cocaine use
Key exclusion criteria (5 listed)
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to cocaine or phendimetrazine
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 |
|---|---|---|
| PhendimetrazineAlso: BontrilPhendimetrazine will be administered in divided doses twice daily. | Drug | Phendimetrazine |
| CocaineIntranasal cocaine will be administered during experimental sessions. | Drug | Phendimetrazine, Placebo |
| PlaceboPlacebo capsules will contain only cornstarch. | Drug | Placebo |
Primary outcome
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
Time frame: After at least seven days of maintenance placebo or target phendimetrazine dose
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 10 choices between a portion of each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both phendimetrazine and placebo maintenance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Phendimetrazine and Cocaine in people with Cocaine Use Disorder, run by William Stoops 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 1 inclusion and 5 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 2 Jul 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 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?
Yes. Results are posted in the registry (first posted 2 Jul 2019). 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?
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative (time frame: After at least seven days of maintenance placebo or target phendimetrazine dose). 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 2 Jul 2019.