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.
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
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- 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
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Heroin Dependence
- 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 group | Role | What they receive |
|---|---|---|
| TREATMENT:Virtual Reality Cue Exposure Therapy (VRCET) | Experimental | 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). Receives: Behavioral: Virtual Reality Cue Exposure Therapy |
| Control: Relapse Prevention Drug Education | Active comparator | 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). Receives: Behavioral: Relapse Prevention Drug Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
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)
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.
- First posted15 Jun 2018
- Study start1 Aug 2014
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Luis R. Torres, PhD, University of Houston
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Houston Drug Abuse Research Development Program II
- ClinicalTrials.gov ID
- NCT03557632
- Acronym / sponsor ID
- UHDARDP-II / 5R24DA019798-08 REVISED
- Conditions
- Heroin Dependence
- Keywords
- Opioid Dependence, Injection Drug Use, Hispanics, Mexican Americans, Virtual Reality Cue Exposure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is examining the impact of a Virtual Reality Cue Exposure Therapy intervention on heroin cravings compared to Relapse Prevention Drug Education.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TREATMENT:Virtual Reality Cue Exposure Therapy (VRCET) | Experimental | Behavioral: Virtual Reality Cue Exposure TherapyVirtual 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 comparator | Behavioral: Relapse Prevention Drug EducationRelapse 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). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Injection or Non-Injection heroin user, 3 or more years of heroin use, Hispanic/Latino
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Cue Exposure TherapyAs above. | Behavioural | TREATMENT:Virtual Reality Cue Exposure Therapy (VRCET) |
| Relapse Prevention Drug EducationAs above. | Behavioural | Control: Relapse Prevention Drug Education |
Primary outcome
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)
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/).
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/).
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/).
1 secondary outcome
Number of times of self-reported drug use in vivo during the week between lab sessions.
Time frame: Continuously during the 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.