Safety and Tolerability of Cocaine During Phendimetrazine Maintenance
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Peak Systolic Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recent cocaine use
排除标准
- •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
研究组 & 干预措施
Placebo
Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Cocaine (Drug)
Placebo
Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Placebo (Drug)
Phendimetrazine Dose 1
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.
干预措施: Cocaine (Drug)
Phendimetrazine Dose 1
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.
干预措施: Placebo (Drug)
Phendimetrazine Dose 2
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.
干预措施: Cocaine (Drug)
Phendimetrazine Dose 2
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.
干预措施: Placebo (Drug)
Phendimetrazine Dose 3
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.
干预措施: Cocaine (Drug)
Phendimetrazine Dose 3
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Peak Systolic Pressure
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Peak Score on Stimulant Subscale of the Adjective Rating Scale(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(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(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(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(This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.)
- Peak Score on Sedative Subscale of the Adjective Rating Scale(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.)
研究者
William Stoops
Associate Professor
University of Kentucky