Recruiting

Observational Study

Sponsor:

University of Houston

Code:

NCT03557632

Conditions

Heroin Dependence

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Virtual Reality Cue Exposure Therapy

Relapse Prevention Drug Education

Study Details

Brief summary:

The study is examining the impact of a Virtual Reality Cue Exposure Therapy intervention on heroin cravings compared to Relapse Prevention Drug Education.

Conditions

Heroin Dependence

Study ID

NCT03557632

Start date

Aug 1, 2014

Status verified date

Aug, 2018

Completion date

Mar 31, 2020

Anticipated

Primary completion date

Aug 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Injection or Non-Injection heroin user, 3 or more years of heroin use, Hispanic/Latino

Exclusion Criteria:

  • Non heroin user, non-Hispanic/Latino, younger than 18 or older than 64, treated with any medications having a potential effect on heroin craving, mood, or heroin cessation medications in the past 30 days; use of other prescription and non-prescription drugs that may affect participation; Fear of closed spaces or inability to wear VR goggles; Visual problems that effect viewing VR materials; History of seizures or seizure disorders; History of serious self-reported health problems; and women who are pregnant

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TREATMENT:Virtual Reality Cue Exposure Therapy (VRCET)

Virtual Reality Cue Exposure Therapy (VRCET) - Active Intervention - comprised of exposure to VR based heroin cues, such as heroin use paraphernalia and scenes of people using injection heroin or snorting heroin. Exposure will be supplemented by the use of a standardized CBT based skills coping protocol teaching relapse prevention skills such as urge surfing, thought stopping and reframing. Lab based reactivity will be measured by self-reported craving on a scale from 0 (none) to 100 (highest ever), heart rate, galvanic skin response, and muscle tension. Secondary outcome measures are number of times of self-reported drug use in vivo as recorded by a cell phone app based Ecological Momentary Assessment Device (EMA).

active comparator: Control: Relapse Prevention Drug Education

Relapse Prevention Drug Education (RPDE) is our Active Comparator. Comprised of watching a series of videos on the health risks of heroin use as well as information about relapse prevention. Lab based reactivity will be measured by self-reported craving on a scale from 0 (none) to 100 (highest ever), heart rate, galvanic skin response, and muscle tension. Secondary outcome measures are number of times of self-reported drug use in vivo as recorded by a cell phone app based Ecological Momentary Assessment Device (EMA).

Interventions

Virtual Reality Cue Exposure Therapy

As above.

Relapse Prevention Drug Education

As above.

Primary outcome measure

  • Self-reported reactivity to cues [ Time Frame: 3 hours (6 blocks of 3 minutes with time in between each block); this is done in two consecutive weeks. ]
  • Lab-based reactivity to cues [ Time Frame: 3 hours (6 blocks of 3 minutes with time in between each block); this is done in two consecutive weeks. These are monitored continuously every 10th of a second. ]
  • Lab-based reactivity to cues [ Time Frame: 3 hours (6 blocks of 3 minutes with time in between each block); this is done in two consecutive weeks. These are monitored continuously every 10th of a second. ]
  • Lab-based reactivity to cues [ Time Frame: 3 hours (6 blocks of 3 minutes with time in between each block); this is done in two consecutive weeks. These are monitored continuously every 10th of a second. ]

Central Contacts and Locations

Central contacts

Luis R Torres, PhD

713-743-8512LRTorres@uh.edu

Micki Washburn, PhD

713-743-0319mewashbu@Central.UH.EDU

Locations

University of Houston Virtual Reality Clinical Research Lab

Recruiting

Houston, Texas, United States, 77204

Contacts

Luis R Torres, PhD

713-743-8512LRTorres@uh.edu

Micki Washburn, PhD

713-743-0319mewashbu@Central.UH.EDU

More Information

Sponsor

University of Houston

Last update posted

Aug 6, 2018

Last verified

Aug, 2018

Keywords

  • Opioid Dependence
  • Injection Drug Use
  • Hispanics
  • Mexican Americans
  • Virtual Reality Cue Exposure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Houston on 2018-08-06.