A Novel Anti-Obesity Drug Combination as a Pharmacotherapy for Cocaine Dependence

NCT01739192 | Completed Early Phase 1 DMC

• 1 other identifier: R01DA032254
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, bupropion and naltrexone, as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of bupropion-naltrexone combinations for managing cocaine dependence.

Conditions

Cocaine Use Disorders

Outcome Measures

Primary Outcomes (1)

• Reinforcing Effects

  The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo, bupropion, naltrexone, and bupropion-naltrexone combinations.

  Twelve (12) times over approximately six (6) weeks inpatient admission.

Secondary Outcomes (2)

• Subjective effects

  Twelve (12) times over approximately six (6) weeks inpatient admission.

• Physiological and side effects.

  Daily over approximately six (6) weeks inpatient admission.

Study Arms (3)

Arm 1

PLACEBO COMPARATOR

Placebo oral daily for approximately six (6) weeks.

Drug: Bupropion

Arm 2

EXPERIMENTAL

Naltrexone (25 mg) oral daily for approximately six (6) weeks.

Drug: Bupropion

Arm 3

EXPERIMENTAL

Naltrexone (50 mg) oral daily for approximately six (6) weeks.

Drug: Bupropion

Interventions

Bupropion DRUG

Subjects will be maintained on oral bupropion or placebo during the study.

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• 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, bupropion or naltrexone,

Sponsors & Collaborators

• Craig Rush: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0086, United States

Location

MeSH Terms

Interventions

Bupropion

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 3, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

US (1)