Opioid Use DisorderNCT06255119
The Feasibility of VR for OUD
A study testing 3D Therapy Thrive in people with Opioid Use Disorder, run by 3D Therapy, LLC at 1 site in United States.
Trial summary
This study aims to evaluate feasibility of a virtual reality software device and measure the effects of the intervention on OUD patient mood, tension and cravings, as well as the effect of treatment on patient retention to their inpatient detox protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- 3D Therapy Thrive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 years or older
- 2. Current diagnosis of opioid use disorder
- 3. Current inpatient in detox ATS unit
- 4. Fluent in English
Who cannot join
- Active suicidality
- History of seizures
- History of psychosis
- Severe visual impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of 3D Therapy Thrive for Inpatients With Opioid Use Disorder
This study aims to evaluate feasibility of a virtual reality software device and measure the effects of the intervention on OUD patient mood, tension and cravings, as well as the effect of treatment on patient retention to their inpatient detox protocol.
Read the detailed description
The primary objective of this study is to evaluate the feasibility and preliminary effectiveness of a novel virtual reality (VR) based intervention; 3D Therapy Thrive (3DTT). Inpatient detoxification can improve outcomes for individuals with opioid use disorder (OUD), however patients often leave treatment early due to mood, tension, and cravings associated with opioid withdrawal. Subjects were recruited from a community inpatient detoxification program and received up to two sessions of 3DTT. The patients completed surveys to assess their mood, distress, cravings, and overall satisfaction with the experience. Retention was measured by protocol completion as reported by clinic staff, independent of the study. A group of patients with OUD consecutively admitted to the program comprised a comparison treatment-as-usual (TAU) group.
- Conditions
- Opioid Use Disorder
- Being tested
- 3D Therapy Thrive
- Keywords
- mood, cravings, retention
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Therapy ThriveDevice
A novel virtual reality software intervention that utilizes elements of Cognitive Behavioral Therapy to improve outcomes for inpatients with OUD.
| Study group | Role | What they receive |
|---|---|---|
| Active VR Group | Active comparator | Participants received the active virtual therapy intervention. Receives: Device: 3D Therapy Thrive |
| Control Group | No intervention | A group of patients concurrently on the ATS unit, otherwise eligible to participate in the study who did not enroll, and did not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in Treatment
Medical record indicating whether patient completed detox protocol (i.e., completed, left against medical advice, administratively discharged, or moved to higher level of care)
Measured: At departure from facility, through study completion, an average of 10 days
Feasibility and Tolerability of 3DTT
Feasibility and tolerability of 3DTT was measured by the Side Effects Questionnaire.
Measured: Immediately after each treatment
Secondary outcomes (3)
Mood
Depressive symptoms as measured by the AB-POMS depression scale (0-4, not at all to extremely)
Measured: Before and after each treatment, approximately every other day for up to 5 days
Anxiety
Anxiety symptoms as measured by the AB-POMS scale (0-4, not at all to extremely)
Measured: Before and after each treatment, approximately every other day for up to 5 days
Cravings
Opioid cravings as measured by the Visual Analog Scale (1-10, with higher scores indicating greater cravings.)
Measured: Before and after each treatment, approximately every other day for up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start18 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3D Therapy, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255119
- Sponsor's protocol ID
- 2022/03/9
- Status last verified
- Oct 2023
- First submitted
- 20 Jun 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of 3D Therapy Thrive for Inpatients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06255119
- Acronym / sponsor ID
- 2022/03/9
- Conditions
- Opioid Use Disorder
- Keywords
- mood, cravings, retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- 3D Therapy, LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Feb 2024 (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.
This study aims to evaluate feasibility of a virtual reality software device and measure the effects of the intervention on OUD patient mood, tension and cravings, as well as the effect of treatment on patient retention to their inpatient detox protocol.
Detailed description
The primary objective of this study is to evaluate the feasibility and preliminary effectiveness of a novel virtual reality (VR) based intervention; 3D Therapy Thrive (3DTT). Inpatient detoxification can improve outcomes for individuals with opioid use disorder (OUD), however patients often leave treatment early due to mood, tension, and cravings associated with opioid withdrawal. Subjects were recruited from a community inpatient detoxification program and received up to two sessions of 3DTT. The patients completed surveys to assess their mood, distress, cravings, and overall satisfaction with the experience. Retention was measured by protocol completion as reported by clinic staff, independent of the study. A group of patients with OUD consecutively admitted to the program comprised a comparison treatment-as-usual (TAU) group.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VR Group | Active comparator | Device: 3D Therapy ThriveParticipants received the active virtual therapy intervention. |
| Control Group | No intervention | –A group of patients concurrently on the ATS unit, otherwise eligible to participate in the study who did not enroll, and did not receive an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.18 years or older
- 2. Current diagnosis of opioid use disorder
- 3. Current inpatient in detox ATS unit
- 4. Fluent in English
Key exclusion criteria (4 listed)
- Active suicidality
- History of seizures
- History of psychosis
- Severe visual impairment
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 |
|---|---|---|
| 3D Therapy ThriveA novel virtual reality software intervention that utilizes elements of Cognitive Behavioral Therapy to improve outcomes for inpatients with OUD. | Device | Active VR Group |
Primary outcome
Retention in Treatment
Time frame: At departure from facility, through study completion, an average of 10 days
Medical record indicating whether patient completed detox protocol (i.e., completed, left against medical advice, administratively discharged, or moved to higher level of care)
Feasibility and Tolerability of 3DTT
Time frame: Immediately after each treatment
Feasibility and tolerability of 3DTT was measured by the Side Effects Questionnaire.
3 secondary outcomes
Mood
Time frame: Before and after each treatment, approximately every other day for up to 5 days
Anxiety
Time frame: Before and after each treatment, approximately every other day for up to 5 days
Cravings
Time frame: Before and after each treatment, approximately every other day for up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Therapy Thrive in people with Opioid Use Disorder, run by 3D Therapy, LLC 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in Treatment (time frame: At departure from facility, through study completion, an average of 10 days). The study lists 2 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 13 Feb 2024.