Interactions Between Intravenous (IV) Cocaine and Lofexidine

NCT01148992 | Terminated Phase 1 DMC

• 1 other identifier: Lofexidine-0001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.

Conditions

Cocaine Related Disorders

Outcome Measures

Primary Outcomes (1)

• Adverse Event and Cardiovascular Response

  Adverse Events will measured during follow-up at weeks 14-21

  Daily, up to 9 days

Secondary Outcomes (4)

• Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)

  Daily, up to 9 days

• PK of Lofexidine

  Daily, up to 9 days

• Visual Analog Scale (VAS)

  Daily, up to 9 days

• Brief Substance Abuse Craving Scale (BSCA)

  Daily, up to 9 days

Study Arms (2)

Lofexidine

ACTIVE COMPARATOR

Drug: Lofexidine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lofexidine DRUG

0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg

Lofexidine

Placebo DRUG

0mg

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Please contact site for more information

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (2)

California Pacific Medical Center Research Institute

San Francisco, California, 94110, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

lofexidine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 23, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: January 11, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)