Clinical trial NCT02233647: Phendimetrazine and Cocaine
Official title: Safety and Tolerability of Cocaine During Phendimetrazine Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Use Disorder
Keywords: cocaine
phendimetrazine
pharmacotherapy
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-09-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Recent cocaine use

Exclusion Criteria:

* 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

Primary outcomes:
measure: Peak Systolic Pressure
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Diastolic Pressure
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Heart Rate
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Temperature
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Secondary outcomes:
measure: Peak Score on Sedative Subscale of the Adjective Rating Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Score on Stimulant Subscale of the Adjective Rating Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Any Effect" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Bad Effect" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Euphoric" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Good Effect" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "High" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Like Drug" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Nauseated/Queasy/Sick to Stomach" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Willing to Pay For" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Performance Impaired" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Performance Improved" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Restless" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Rush" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Stimulated" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Willing to Take Again" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
measure: Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale
timeFrame: This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Laboratory of Human Behavioral Pharmacology
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: William W Stoops, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: