Reinforcing Effects of Cocaine During Phendimetrazine Maintenance (BED IN 31)

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.

Study Overview

• Status: Completed
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Drug: Cocaine; Drug: Placebo; Drug: Phendimetrazine

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0086
      • University of Kentucky Department of Behavioral Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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.	Drug: Cocaine; Intranasal cocaine will be administered during experimental sessions.; Drug: Placebo; Placebo capsules will contain only cornstarch.
Experimental: Phendimetrazine; 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.	Drug: Cocaine; Intranasal cocaine will be administered during experimental sessions.; Drug: Phendimetrazine; Phendimetrazine will be administered in divided doses twice daily.; Other Names: Bontril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After at least seven days of maintenance placebo or target phendimetrazine dose

Collaborators and Investigators

• Sponsor: William Stoops
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Anesthetics, Local; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Vasoconstrictor Agents; Cocaine; Phendimetrazine
• Other Study ID Numbers: 15-0553; R01DA036553 (U.S. NIH Grant/Contract)