Cocaine Use DisorderEarly Phase 1NCT02233647
Phendimetrazine and Cocaine
A Early Phase 1 study testing Cocaine in people with Cocaine Use Disorder, run by William Stoops at 1 site in United States.
Trial summary
This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will be conducted in which the subjective and physiological 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?
- Cocaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- Phase
- Early 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 Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, 40507
About this study
Official title: Safety and Tolerability of Cocaine During Phendimetrazine Maintenance
This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will be conducted in which the subjective and physiological effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.
- Conditions
- Cocaine Use Disorder
- Being tested
- Cocaine, Placebo
- Keywords
- cocaine, phendimetrazine, pharmacotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocaineDrug
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine.
PlaceboDrug
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. Receives: Drug: Cocaine; Drug: Placebo |
| Phendimetrazine Dose 1 | Experimental | Subjects will be maintained on the low phendimetrazine dose. Cocaine will be administered acutely during low dose phendimetrazine maintenance.
Placebo will be administered acutely during low dose phendimetrazine maintenance. Receives: Drug: Cocaine; Drug: Placebo |
| Phendimetrazine Dose 2 | Experimental | Subjects will be maintained on the intermediate phendimetrazine dose. Cocaine will be administered acutely during intermediate dose phendimetrazine maintenance.
Placebo will be administered acutely during intermediate dose phendimetrazine maintenance. Receives: Drug: Cocaine; Drug: Placebo |
| Phendimetrazine Dose 3 | Experimental | Subjects will be maintained on the high phendimetrazine dose. Cocaine will be administered acutely during high dose phendimetrazine maintenance.
Placebo will be administered acutely during high dose phendimetrazine maintenance. Receives: Drug: Cocaine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Systolic Pressure
Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Diastolic Pressure
Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Heart Rate
Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Temperature
Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Secondary outcomes (22)
Peak Score on Sedative Subscale of the Adjective Rating Scale
Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 "sedative" items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Score on Stimulant Subscale of the Adjective Rating Scale
Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 "stimulant" items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale
Subjects rated their feelings of "Active, Alert, Energetic" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Any Effect" on the Visual Analog Scale
Subjects rated their feelings of "Any Effect" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Bad Effect" on the Visual Analog Scale
Subjects rated their feelings of "Bad Effect" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Euphoric" on the Visual Analog Scale
Subjects rated their feelings of "Euphoric" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Good Effect" on the Visual Analog Scale
Subjects rated their feelings of "Good Effect" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "High" on the Visual Analog Scale
Subjects rated their feelings of "High" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale
Subjects rated their feelings of "Irregular/Racing Heartbeat" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Like Drug" on the Visual Analog Scale
Subjects rated their feelings of "Like Drug" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale
Subjects rated their feelings of "Nauseated/Queasy/Sick to Stomach" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale
Subjects rated their feelings of "Nervous/Anxious" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale
Subjects rated their feelings of "Willing to Pay For" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Performance Impaired" on the Visual Analog Scale
Subjects rated their feelings of "Performance Impaired" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Performance Improved" on the Visual Analog Scale
Subjects rated their feelings of "Performance Improved" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Restless" on the Visual Analog Scale
Subjects rated their feelings of "Restless" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Rush" on the Visual Analog Scale
Subjects rated their feelings of "Rush" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale
Subjects rated their feelings of "Shaky/Jittery" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale
Subjects rated their feelings of "Sluggish/Fatigued/Lazy" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Stimulated" on the Visual Analog Scale
Subjects rated their feelings of "Stimulated" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale
Subjects rated their feelings of "Willing to Take Again" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale
Subjects rated their feelings of "Talkative/Friendly" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions.
Measured: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 11 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
- Investigators
- William W Stoops, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233647
- Sponsor's protocol ID
- BED (IN) 29
- Status last verified
- Sep 2017
- First submitted
- 3 Sep 2014
- Last updated
- 27 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Cocaine During Phendimetrazine Maintenance
- ClinicalTrials.gov ID
- NCT02233647
- Acronym / sponsor ID
- BED (IN) 29
- Conditions
- Cocaine Use Disorder
- Keywords
- cocaine, phendimetrazine, pharmacotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- William StoopsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Posted 15 Sep 2016
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 safety and tolerability of phendimetrazine (Bontril®) as a pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will be conducted in which the subjective and physiological effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Cocaine, Drug: PlaceboSubjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
| Phendimetrazine Dose 1 | Experimental | Drug: Cocaine, Drug: PlaceboSubjects will be maintained on the low phendimetrazine dose. Cocaine will be administered acutely during low dose phendimetrazine maintenance. Placebo will be administered acutely during low dose phendimetrazine maintenance. |
| Phendimetrazine Dose 2 | Experimental | Drug: Cocaine, Drug: PlaceboSubjects will be maintained on the intermediate phendimetrazine dose. Cocaine will be administered acutely during intermediate dose phendimetrazine maintenance. Placebo will be administered acutely during intermediate dose phendimetrazine maintenance. |
| Phendimetrazine Dose 3 | Experimental | Drug: Cocaine, Drug: PlaceboSubjects will be maintained on the high phendimetrazine dose. Cocaine will be administered acutely during high dose phendimetrazine maintenance. Placebo will be administered acutely during high dose phendimetrazine 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 |
|---|---|---|
| CocaineThe pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine. | Drug | Phendimetrazine Dose 1, Phendimetrazine Dose 2, Phendimetrazine Dose 3, Placebo |
| PlaceboThe pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine. | Drug | Phendimetrazine Dose 1, Phendimetrazine Dose 2, Phendimetrazine Dose 3, Placebo |
Primary outcome
Peak Systolic Pressure
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Diastolic Pressure
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Heart Rate
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Temperature
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.
22 secondary outcomes
Peak Score on Sedative Subscale of the Adjective Rating Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Score on Stimulant Subscale of the Adjective Rating Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Any Effect" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Bad Effect" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Euphoric" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Good Effect" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "High" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Like Drug" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Willing to Pay For" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Performance Impaired" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Performance Improved" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Restless" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Rush" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Stimulated" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Willing to Take Again" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale
Time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- 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.
William W Stoops, Ph.D. principal investigator
University of Kentucky
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 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 27 Sep 2017. 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?
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?
Yes. Results are posted in the registry (first posted 15 Sep 2016). 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?
Peak Systolic Pressure (time frame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.). The study lists 4 primary outcomes in all. 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 Sep 2017; AzTrials last refreshed its copy on 31 Oct 2026.