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Interactions Between Intravenous (IV) Cocaine and Lofexidine

Primary Purpose

Cocaine Related Disorders

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lofexidine
Placebo
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Related Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.
  • Be between 18 and 50 years of age, inclusive.
  • Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.
  • Be able to verbalize understanding of the consent form and provide written informed consent.

  • Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:

    • diaphragm and condom by partner
    • intrauterine device (that does not contain progesterone) and condom by partner
    • sponge and condom by partner
    • complete abstinence from sexual intercourse

Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.

Exclusion Criteria:

  • Please contact site for more information

Sites / Locations

  • California Pacific Medical Center Research Institute
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lofexidine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Adverse Event and Cardiovascular Response
Adverse Events will measured during follow-up at weeks 14-21

Secondary Outcome Measures

Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)
PK of Lofexidine
Visual Analog Scale (VAS)
Brief Substance Abuse Craving Scale (BSCA)

Full Information

First Posted
June 17, 2010
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01148992
Brief Title
Interactions Between Intravenous (IV) Cocaine and Lofexidine
Official Title
Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Lofexidine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
Detailed Description
To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lofexidine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lofexidine
Intervention Description
0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0mg
Primary Outcome Measure Information:
Title
Adverse Event and Cardiovascular Response
Description
Adverse Events will measured during follow-up at weeks 14-21
Time Frame
Daily, up to 9 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)
Time Frame
Daily, up to 9 days
Title
PK of Lofexidine
Time Frame
Daily, up to 9 days
Title
Visual Analog Scale (VAS)
Time Frame
Daily, up to 9 days
Title
Brief Substance Abuse Craving Scale (BSCA)
Time Frame
Daily, up to 9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study. Be between 18 and 50 years of age, inclusive. Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period. Be able to verbalize understanding of the consent form and provide written informed consent. Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control: diaphragm and condom by partner intrauterine device (that does not contain progesterone) and condom by partner sponge and condom by partner complete abstinence from sexual intercourse Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed. Exclusion Criteria: Please contact site for more information
Facility Information:
Facility Name
California Pacific Medical Center Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Interactions Between Intravenous (IV) Cocaine and Lofexidine

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