NCT00276874

Brief Summary

Despite the many behavioral and cognitive treatment therapies that exist for cocaine addiction, individuals who complete cocaine abuse treatment are still at high risk for relapsing. Aripiprazole, a medication that is currently used to treat schizophrenia, may be useful in preventing drug relapse in individuals addicted to cocaine. This three-part study will evaluate the interaction between aripiprazole and cocaine. It will also determine the safety and effectiveness of aripiprazole in preventing drug relapse among cocaine addicts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

6 years

First QC Date

January 11, 2006

Last Update Submit

April 5, 2017

Conditions

Cocaine-Related Disorders

Keywords

Cocaine AddictionCocaine Dependence

Outcome Measures

Primary Outcomes (1)

  • Behavioral effects of cocaine

    Measured throughout the study

Secondary Outcomes (1)

  • Heart rate; blood pressure; ECG

    Measured throughout the study

Study Arms (2)

Aripiprazole

EXPERIMENTAL

Subjects receive oral aripiprazole.

Drug: Aripiprazole

Placebo

PLACEBO COMPARATOR

Subjects receive oral placebo

Drug: Placebos

Interventions

AripiprazoleDRUG

Aripiprazole; 0-30 mg; oral; daily

Also known as: Abilify
Aripiprazole
PlacebosDRUG

Placebo; 0 mg; oral; daily

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets DSM-IV diagnostic criteria for cocaine dependence
  • Current cocaine use at study entry, as determined by a urine screen
  • Body Mass Index of less than 30
  • ECG results within normal limits
  • If female, willing to use contraception throughout the study

You may not qualify if:

  • Meets DSM-IV diagnostic criteria for dependence on any drugs other than cocaine or nicotine
  • Currently seeking treatment for substance abuse
  • Current or past serious illness, including impaired heart function, seizures, head trauma, or central nervous system tumors
  • A family history of heart disease or seizures
  • Current or past psychiatric disorder, other than substance abuse
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Craig R. Rush, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

  • Paul E Glaser, MD, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

  • Lon R. Hays, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

  • Joshua A. Lile, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2006

First Posted

January 13, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

US(1)