NCT00586534

Brief Summary

The purpose of our research is to examine the promise of a new computer based approach to use in usual drug counseling when treating crack cocaine addiction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

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, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

7.8 years

First QC Date

December 21, 2007

Last Update Submit

March 17, 2015

Conditions

Cocaine Addiction

Keywords

crack, cocaine, addiction treatment, virtual reality

Outcome Measures

Primary Outcomes (1)

  • Urinalyses

    urinary analysis will be conducted three times weekly during 24 weeks of active treatment. During the booster phase (months 7-9), UA's will occur once monthly, before the booster sessions and again at 12 months. Urine will be tested for cocaine, marijuana, opiates, amphetamines, and benzodiazepines

    1 year

Secondary Outcomes (4)

  • Physiological measures: skin conductance, heart rate, and skin temperature

    Intake, 6 month, 9 month, and 12 month follow-up assessments

  • Interview measures: Structured Clinical Interview for DSM-IV, Axis I (SCID-I), Addiction Severity Index

    Intake, 6 month, 9 month, and 12 month assessments.

  • Self-report measures of Substance use [e.g., TLFB; Minnesota Cocaine Craving Questionnaire (MCCS); Cocaine Craving Questionnaire (CCQ)]

    Intake assessment, 6 months, 9months, 12 months

  • HIV Risk Behaviors

    6 months, 9 months, 12 months

Study Arms (2)

I/GDC

ACTIVE COMPARATOR

NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment

Behavioral: I/GDC

I/GDC + VR/CER

EXPERIMENTAL

Second Arm:NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment plus virtual reality (VR) based cue exposure/extinction software and cellular phone-based computerized extinction reminder (CER) technology for use in high-risk situations outside treatment sessions.

Behavioral: I/GDC + VR/CER

Interventions

I/GDC + VR/CERBEHAVIORAL

NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment plus virtual reality (VR) based cue exposure/extinction software and cellular phone-based computerized extinction reminder (CER) technology for use in high-risk situations outside treatment sessions.

Also known as: drug counseling, group drug counseling, individual drug counseling, virtual reality, exposure/extinction software, cellular phone based computerized extinction reminder
I/GDC + VR/CER
I/GDCBEHAVIORAL

NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment

Also known as: drug counseling, group drug counseling, individual drug counseling
I/GDC

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets SCID-I criteria for cocaine dependence; crack cocaine is primary substance of abuse
  • Consents to outpatient treatment for drug addiction
  • Resides within commuting distance of treatment

You may not qualify if:

  • Full criteria met for psychotic disorders
  • Full criteria met for current mania
  • IQ less than 70
  • Unable to give consent
  • Can not read
  • Current and chronic absence of shelter
  • Impending jail/prison for more than three weeks (problems which by their presence or severity preclude ability to attend or understand treatment and/or requires priority treatment over substance use treatment)
  • Court order to treatment or to jail, or agency order to treatment or loss of child custody (due to inability to freely drop-out of treatment)
  • Refuses to discontinue current drug abuse treatment or refuses random assignment
  • If the potential participant lives with or is in an intimate relationship with another participant currently being treated in the study, they will be told that they cannot participate until that housemate or partner has completed treatment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Zachary Rosenthal, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

January 1, 2007

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(1)