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Heroin DependenceUHDARDP-IINCT03557632

University of Houston Drug Abuse Research Development Program II

A study testing Virtual Reality Cue Exposure Therapy and Relapse Prevention Drug Education in people with Heroin Dependence, run by University of Houston at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Heroin Dependence
What is being tested?
Virtual Reality Cue Exposure Therapy and Relapse Prevention Drug Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Aug 2014to 31 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Luis R Torres, PhD contact

713-743-8512

LRTorres@uh.edu

Micki Washburn, PhD contact

713-743-0319

mewashbu@Central.UH.EDU

United States1 site, 1 recruiting
  • University of Houston Virtual Reality Clinical Research Lab

    Houston, Texas, 77204

    Luis R Torres, PhD, 713-743-8512, LRTorres@uh.edu

    Micki Washburn, PhD, 713-743-0319, mewashbu@Central.UH.EDU

    Recruiting

Other trials in United States

About this study

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

Read the detailed description

Injection Drug Use (IDU) is a chronic, relapsing condition with grave individual and public health consequences.19-21 A majority (53%) of all past-year IDUs prefer heroin, as do 39% of single-drug injectors, second only to Methamphetamine.22,23 Non-injection heroin use (NIDU) is increasing, due to growing awareness of IDU risks, particularly HIV/AIDS;21,24-26 increased purity of street heroin;27-29 greater regulation of other opiates;30,31 and opioid abusers switching to heroin for its lower cost.32 Many NIDUs transition to IDU, incurring greater risks.2,21,33,34 Drug cravings are intense urges to use drugs35,36 and they contribute to drug use37, relapse38, and transitioning from NIDU to IDU.39 Cravings are triggered by environmental factors and due to the significance of craving in drug use and relapse they will be part of the proposed criteria for DSM5.40,41

HIV, Hepatitis C (HCV), and Sexually-Transmitted Infections (STIs) continue to be associated with both IDU and NIDU.33,42-44 Hispanics are over-represented among both IDU and NIDU heroin users.21,23,45,46 Mexican American IDUs have very low rates of HIV.10,47 However, their HCV rates are very high and continue to increase, further compromising their health.10,48,49 They also have elevated rates of high-risk sex behaviors 33,50 and they are less likely to decrease these high-risk sex behaviors than they are to decrease their injection- behavior risks, especially as they age.10,51 Furthermore, HIV/HCV/STI prevention interventions can lead to fatigue52-54 so they must continue to be delivered to at-risk populations across all relevant settings. Young Texans ages 15-24 are becoming HIV infected at high rates, with Hispanics disproportionately impacted and diagnosed later: 42% of infected Texan Hispanics receive an HIV-positive and an AIDS diagnosis within the same year, compared to 32% of Anglos and 31% of Blacks.55 Thus, early detection of high-risk Hispanics is vital, making this proposal timely and critical.

Greatly needed are novel interventions that address drug cravings (DCs), take into account environmental context, and incorporate HIV/HCV prevention components. Developing these interventions and adapting them to the many diverse at-risk populations, however, can be costly and challenging. Cue exposure therapy (CET)56,57 may be a viable approach. CET is a promising intervention that can decrease DCs by repeatedly exposing an individual to a craving inducing stimulus (e.g., a shooting gallery scenario) while simultaneously preventing the conditioned behavioral response (e.g., drug use). The individual can be trained in vitro (in the lab) to use coping skills in direct response to activated cravings, then use these skills in vivo (in the natural environment). A challenge associated with CET, for both ethical and logistical reasons, is the ability to expose individuals to realistic simulated cues of the natural environment in a secure laboratory or therapeutic setting. Virtual Reality (VR) is an innovative, cutting-edge tool that can enable researchers to overcome these obstacles. VR scenarios integrate elements from the individual's various contexts-culture, neighborhood, family, networks, and individual characteristics-into the clinical or lab setting, and provide complex multi-sensory cues through an immersive human-computer interaction.58

The public health significance of this primary project is high. Drug use in general and injection drug use (IDU) in particular are serious public health concerns, as are the rates of HCV and STIs in IDUs. Interventions that decrease craving, increase coping skills, and incorporate HIV/HCV/STI prevention components can be critical tools in treating drug use disorders and their serious health consequences. In addition, it is critical to train diverse researchers who possess intimate knowledge of the populations impacted by drug use and who understand the cultural and contextual elements of those populations, to conduct this innovative research.

The specific research hypotheses and objectives are as follows:

  1. Refine and develop a Virtual Reality Heroin Scenario (VRHS) using qualitative data (i.e., photos and descriptions of heroin using sites and contexts) from our current UHDARDP's Primary Project.
  2. Measure the effects of exposure to virtual reality heroin cues on craving and physiological reactivity. Hypothesis 1a: VR cues will increase subjective heroin craving and physiological reactivity. Hypothesis 1b: Heroin craving and physiological reactivity will decrease as a result of repeated exposure to virtual cues.
  3. Compare Virtual Reality-Based Cue Exposure Therapy (VRCET) and Relapse Prevention Drug Education (RPDE) on extinction of heroin craving and physiological reactivity across cue trials. Hypothesis 2: VRCET will attenuate cue-elicited subjective heroin craving and physiological reactivity relative to RPDE.
  4. Examine the in vivo effects of VRCET on heroin craving, craving coping skills, and actual heroin use, compared to RPDE. Hypothesis 3: VRCET will lead to a decrease in heroin craving, an increase in craving coping skills use, and decreased heroin use, in the natural environment, compared to RPDE.
  5. Deliver an HIV/HCV prevention intervention to this high-risk population. Hypothesis 4: The prevention intervention will increase prevention knowledge and intention to use the skills learned.
  6. Determine if medication assisted therapies, such as methadone or buprenorphine, have an impact on cue reactivity for former heroin IDU when immersed in the virtual environments, as compared to current users.

Hypothesis 5: Participants on medication assisted therapies will exhibit lower levels of cue reactivity within the VR environment than participants who are currently still using heroin.

Being tested
Virtual Reality Cue Exposure Therapy, Relapse Prevention Drug Education
Keywords
Opioid Dependence, Injection Drug Use, Hispanics, Mexican Americans, Virtual Reality Cue Exposure
Medical subject headings
Heroin Dependence, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Cue Exposure TherapyBehavioural

    As above.

  • Relapse Prevention Drug EducationBehavioural

    As above.

Study groups in NCT03557632
Study groupRoleWhat they receive
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).
Receives: Behavioral: Virtual Reality Cue Exposure Therapy
Control: Relapse Prevention Drug EducationActive 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).
Receives: Behavioral: Relapse Prevention Drug Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported reactivity to cues

    Self-reported craving on a scale from 0 (none) to 100 (highest ever)

    Measured: 3 hours (6 blocks of 3 minutes with time in between each block); this is done in two consecutive weeks.

  2. 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/).

    Measured: 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.

  3. Lab-based reactivity to cues

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

    Measured: 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.

  4. Lab-based reactivity to cues

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

    Measured: 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)
  1. Number of times of self-reported drug use in vivo during the week between lab sessions.

    As recorded by a cell phone app based Ecological Momentary Assessment Device (EMA)

    Measured: Continuously during the 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2018
  2. Study start1 Aug 2014
  3. Primary completion31 Aug 2019 (estimated)
  4. Study completion31 Mar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03557632
Sponsor's protocol ID
5R24DA019798-08 REVISED
Other IDs
5R24DA019798
Acronym
UHDARDP-II
Status last verified
Aug 2018
First submitted
17 Apr 2018
Last updated
6 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Cue Exposure Therapy and Relapse Prevention Drug Education in people with Heroin Dependence, run by University of Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luis R Torres, PhD (713-743-8512, LRTorres@uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.

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