University of Houston Drug Abuse Research Development Program II
UHDARDP-II
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 17, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedAugust 6, 2018
August 1, 2018
5.1 years
April 17, 2018
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Self-reported reactivity to cues
Self-reported craving on a scale from 0 (none) to 100 (highest ever)
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
Heart rate (ECG) assessed in beats per minute using a Bioradio Wireless Physiology (see https://glneurotech.com/bioradio/psychophysiology-equipment/).
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
Galvanic skin response (GSR) assessed using a Bioradio Wireless Physiology (see https://glneurotech.com/bioradio/psychophysiology-equipment/).
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
Changes in muscle tension (EMG) assessed using a Bioradio Wireless Physiology (see https://glneurotech.com/bioradio/psychophysiology-equipment/).
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.
Secondary Outcomes (1)
Number of times of self-reported drug use in vivo during the week between lab sessions.
Continuously during the 4 weeks
Study Arms (2)
TREATMENT:Virtual Reality Cue Exposure Therapy (VRCET)
EXPERIMENTALVirtual 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).
Control: Relapse Prevention Drug Education
ACTIVE COMPARATORRelapse 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
As above.
Eligibility Criteria
You may qualify if:
- Injection or Non-Injection heroin user, 3 or more years of heroin use, Hispanic/Latino
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Houstonlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Houston Virtual Reality Clinical Research Lab
Houston, Texas, 77204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 17, 2018
First Posted
June 15, 2018
Study Start
August 1, 2014
Primary Completion
August 31, 2019
Study Completion
March 31, 2020
Last Updated
August 6, 2018
Record last verified: 2018-08