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University of Houston Drug Abuse Research Development Program II (UHDARDP-II)

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ClinicalTrials.gov Identifier: NCT03557632
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Luis R. Torres, PhD, University of Houston

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.

Condition or disease Intervention/treatment Phase
Heroin Dependence Behavioral: Virtual Reality Cue Exposure Therapy Behavioral: Relapse Prevention Drug Education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The proposed study will use a between-groups, randomized controlled experimental design to test the effects of Virtual Reality Cue Exposure Therapy (VRCET) compared to Relapse Prevention Drug Education (RPDE) on self-reported drug craving, physiological reactivity (i.e., Galvanic Skin Conductance [GSC] and heart rate [HR]), craving coping skills, and drug use among Mexican American IDUs and NIDUs with heroin as their primary drug of choice (see design below). All participants who are former IDU will not be randomized and will complete the VRCET protocol.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: University of Houston Drug Abuse Research Development Program II
Actual Study Start Date : August 1, 2014
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Arm Intervention/treatment
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).
Behavioral: Virtual Reality Cue Exposure Therapy
As above.

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).
Behavioral: Relapse Prevention Drug Education
As above.




Primary Outcome Measures :
  1. 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. ]
    Self-reported craving on a scale from 0 (none) to 100 (highest ever)

  2. 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. ]
    Heart rate (ECG) assessed in beats per minute using a Bioradio Wireless Physiology (see https://glneurotech.com/bioradio/psychophysiology-equipment/).

  3. 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. ]
    Galvanic skin response (GSR) assessed using a Bioradio Wireless Physiology (see https://glneurotech.com/bioradio/psychophysiology-equipment/).

  4. 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. ]
    Changes in muscle tension (EMG) assessed using a Bioradio Wireless Physiology (see https://glneurotech.com/bioradio/psychophysiology-equipment/).


Secondary Outcome Measures :
  1. Number of times of self-reported drug use in vivo during the week between lab sessions. [ Time Frame: Continuously during the 4 weeks ]
    As recorded by a cell phone app based Ecological Momentary Assessment Device (EMA)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557632


Contacts
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Contact: Luis R Torres, PhD 713-743-8512 LRTorres@uh.edu
Contact: Micki Washburn, PhD 713-743-0319 mewashbu@Central.UH.EDU

Locations
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United States, Texas
University of Houston Virtual Reality Clinical Research Lab Recruiting
Houston, Texas, United States, 77204
Contact: Luis R Torres, PhD    713-743-8512    LRTorres@uh.edu   
Contact: Micki Washburn, PhD    713-743-0319    mewashbu@Central.UH.EDU   
Sponsors and Collaborators
University of Houston
National Institute on Drug Abuse (NIDA)

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Responsible Party: Luis R. Torres, PhD, Associate Professor, University of Houston
ClinicalTrials.gov Identifier: NCT03557632     History of Changes
Other Study ID Numbers: 5R24DA019798-08 REVISED
5R24DA019798 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luis R. Torres, PhD, University of Houston:
Opioid Dependence
Injection Drug Use
Hispanics
Mexican Americans
Virtual Reality Cue Exposure
Additional relevant MeSH terms:
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Substance-Related Disorders
Heroin Dependence
Chemically-Induced Disorders
Mental Disorders
Opioid-Related Disorders