Phendimetrazine and Cocaine

NCT02233647 | Completed Early Phase 1 Results

• 1 other identifier: BED (IN) 29
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Use Disorder

Keywords

cocaine; phendimetrazine; pharmacotherapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  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 "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 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.

Study Arms (4)

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.

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.

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.

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.

Drug: Cocaine; Drug: Placebo

Interventions

Cocaine DRUG

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine.

Phendimetrazine Dose 1; Phendimetrazine Dose 2; Phendimetrazine Dose 3; Placebo

Placebo DRUG

The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.

Phendimetrazine Dose 1; Phendimetrazine Dose 2; Phendimetrazine Dose 3; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recent cocaine use

You may not qualify if:

• 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

Sponsors & Collaborators

• William Stoops: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, 40507, United States

Location

MeSH Terms

Interventions

Cocaine

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: William W. Stoops, Ph.D.
• Organization: University of Kentucky

william.stoops@uky.edu

859-257-5388

Study Officials

• William W Stoops, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 8, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 27, 2017
• Results First Posted: September 15, 2016

Record last verified: 2017-09

Locations

US (1)