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Completed

NCT Number: NCT02522325

Reinforcing Effects of Cocaine During Phendimetrazine Maintenance

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.

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Key information

Conditions

Cocaine Use Disorder

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky Department of Behavioral Science

Lexington, Kentucky, 40536-0086, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phendimetrazine

Drug

Phendimetrazine will be administered in divided doses twice daily.

Other names: Bontril

Cocaine

Drug

Intranasal cocaine will be administered during experimental sessions.

Placebo

Drug

Placebo capsules will contain only cornstarch.

Primary outcomes

  1. Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative

    Time frame: After at least seven days of maintenance placebo or target phendimetrazine dose

    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.

Sponsors and collaborators

Lead sponsor

William Stoops

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Behavioral Effects of Drugs (Inpatient): 31 (Cocaine and Phendimetrazine)

Acronym: BED IN 31

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2015
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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