Developing Computer Based Treatments for Addiction

Cocaine Addiction Clinical Trial

Official title:

Developing Computer Based Treatments for Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586534
• Other study ID #: Pro00011048
• Secondary ID: R01DA026454
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: March 17, 2015
• Start date: January 2007
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This is the next part of the project under a National Institute of Drug Abuse-funded R01 treatment development study with the purpose of developing a computer-based augmentation of standard drug counseling for cocaine dependence. This project has received additional funding from NIDA. Specifically, the aims of the next part of the proposal are to develop and manualize a cue-exposure based cocaine treatment using 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. We will enroll a total of 270 cocaine dependent subjects in order to meet the target goal of 180 subjects in treatment. This randomized clinical trial will be conducted in order to determine the acceptability and feasibility of this treatment to subjects and therapists, and to obtain treatment outcome effect size estimates. Specifically, during the next stage of the study, 180 cocaine dependent individuals will be randomly assigned to receive a NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment or I/GDC plus VR/CER. Matching between treatment groups will be based on age, sex, severity of crack use (using the Addiction Severity Index), and presence or absence of antisocial personality disorder. Treatment assignment will be conducted using a computerized urn matching program by the off-site study statistician. Current psychiatric diagnoses will be assessed, as will changes in crack use. Comprehensive assessments will be conducted during treatment at baseline, and at a six-month and twelve-month follow-up. To measure outcomes, substance use will be assessed via self-report and urinary analysis three times weekly during 24 weeks of active treatment and weekly during six month and twelve month of follow-up assessment.

This new larger part of project follows work we have conducted in a NIDA-funded pilot project over the past four years, developing the complementary intervention. In our preliminary studies (Phase I a/b), we conducted focus groups, an open trial, and a small randomized controlled trial (n = 53) to demonstrate the promise of the novel intervention. The pilot phase I a/b portion enrolled 171 subjects (signed consent) at Duke. 19 of 53 completed the treatment portion. During Phase 1a, the VR and CER technology was developed and refined using two small open clinical trials. At the conclusion of Phase 1a, a treatment manual detailing the rationale and parameters of VR and CER technology was completed. Next, as mentioned, a Phase Ib pilot randomized clinical trial was conducted in order to determine the acceptability and feasibility of this treatment to patients and therapists, and to obtain treatment outcome effect size estimates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior, Addictive
• Cocaine Addiction

Intervention

Behavioral:
• I/GDC + VR/CER
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.
• I/GDC
NIDA approved Individual/Group Drug Counseling (I/GDC) cocaine treatment

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Physiological measures: skin conductance, heart rate, and skin temperature	They will be measured using Ag-AgCl electrodes. They will be measured during a 5 minute videotape showing cocaine paraphernalia and use.	Intake, 6 month, 9 month, and 12 month follow-up assessments	No
Secondary	Interview measures: Structured Clinical Interview for DSM-IV, Axis I (SCID-I), Addiction Severity Index		Intake, 6 month, 9 month, and 12 month assessments.	No
Secondary	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	No
Secondary	HIV Risk Behaviors	The 11-item HIV Risk Behavior Scale (a brief self-report measure using a 6-point Likert-type scale, will be utilized at each time point.	6 months, 9 months, 12 months	No