Substance UseNCT07042451
An Evaluation of the Pink Cloud Application in Post- Treatment Substance Use Disorder Support
A study testing Pink Cloud in people with Substance Use, run by Loyola Marymount University at 1 site in United States.
Trial summary
This randomized controlled trial (RCT) will evaluate the feasibility and efficacy of Pink Cloud, a mobile health application designed to support recovery from substance and alcohol use disorders (SUD/AUD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Pink Cloud
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,410 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is 18 years of age or older
- Participant is willing to attend a 12-Step or peer-to-peer recovery meeting (in person or virtual) within the next week
- Participant owns a personal smartphone with cellular service
- Participant is a permanent resident of the United States
- Participant feels comfortable reading and understanding written English in everyday situations
- Participant has consumed alcohol and/or used drugs (excluding tobacco or prescribed medication) at some point in their life, but not within the past couple of days
Show all 10Show fewer
- Participant is not currently attending outpatient or residential treatment for substance and/or alcohol use
- Participant does not have a plan to enter substance and/or alcohol treatment in the next 30 days
- Participant has been invited by the research team to either the intervention or control condition and redeemed their subscription code.
- Informed consent is provided
Who cannot join
- Participant is younger than 18 years of age
- Participant is unwilling to attend a 12-Step or peer-to-peer recovery meeting (in person or virtual) within the next week
- Participant does not own a personal smartphone with cellular service
- Participant is not a permanent resident of the United States
- Participant does not feel comfortable reading and understanding written English in everyday situations
- Participant has consumed alcohol or used drugs (excluding tobacco or prescribed medication) within the past couple of days
Show all 11Show fewer
- Participant has never consumed alcohol or used drugs
- Participant is currently attending outpatient or residential treatment for substance and/or alcohol use
- Participant has a plan to enter substance and/or alcohol treatment in the next 30 days
- Participant was not invited by the research team or did not redeem their assigned subscription code
- Informed consent is not provided
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loyola Marymount
Los Angeles, California, 90045
Bradley M Trager, PhD, 3103383701, bradley.trager@lmu.edu
Joseph W LaBrie, PhD, 3103385238, jlabrie@lmu.edu
About this study
Official title: Digital Aftercare Assessed: An Evaluation of the Pink Cloud Application in Post-Treatment Substance Use Disorder Support
This randomized controlled trial (RCT) will evaluate the feasibility and efficacy of Pink Cloud, a mobile health application designed to support recovery from substance and alcohol use disorders (SUD/AUD). The app provides access to over 245,000 in-person and virtual 12-Step meetings, along with features such as a sobriety counter, daily planner, and personal inventory tools. In this study, 1,410 participants in various stages of recovery will be randomly assigned to receive either access to the Pink Cloud app or to a control condition. Participants will complete follow-up assessments at 1, 3, and 6 months. Primary outcomes include number of days sober and frequency of drug and alcohol problems. Secondary outcomes include meeting attendance, proportion of sober individuals in one's social network, and engagement in recovery-related activities. The investigators hypothesize that participants in the Pink Cloud group will report more days sober and fewer substance use problems than those in the control group, and that they will also report attending more meetings, having a greater proportion of sober peers, and engaging more frequently in recovery activities.
- Conditions
- Substance Use
- Being tested
- Pink Cloud, Active Control
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pink CloudBehavioural
Participants randomized to the Pink Cloud condition will receive a subscription code to access the Pink Cloud mobile application for approximately 365 days. The app includes features such as a searchable database of over 245,000 12-Step meetings (in-person and virtual), a sobriety counter, customizable daily planners, personal inventory tools, and a resentment journal. Participants are encouraged to use the app as they see fit throughout the study period. No prompts or required usage schedules will be imposed; instead, engagement will be self-directed to reflect real-world usage patterns.
Active ControlBehavioural
Participants randomized to the control condition will receive a code to access recovery-related resources hosted on a private study website. These materials include links to mutual-help groups, crisis support services, and educational content and treatment options. Participants may access the website at their discretion and engage with the resources as often and in whatever ways they choose. No prompts or required usage schedules will be imposed.
| Study group | Role | What they receive |
|---|---|---|
| Pink Cloud | Experimental | Participants in this arm will receive access to a mobile application designed to support ongoing recovery from substance and alcohol use disorders. The app includes tools that promote engagement with 12-Step recovery principles and offer self-monitoring features. Participants can integrate the app into their recovery efforts as they see fit throughout the study period. Receives: Behavioral: Pink Cloud |
| Active Control | Active comparator | Participants in this arm will receive access to a website containing curated recovery-related materials. These resources are intended to offer general support for individuals in recovery, without emphasizing any specific program or approach. Participants are free to explore and use the content as they choose. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sobriety status between baseline and 1 month
Self-reported number of days participant reports not using alcohol or drugs in the past 30 days.
Measured: baseline, 1 month
Change in sobriety status between baseline and 3 months
Self-reported number of days participant reports not using alcohol or drugs in the past 90 days.
Measured: baseline, 3 months
Change in sobriety status between baseline and 6 months
Self-reported number of days participant reports not using alcohol or drugs in the past 180 days.
Measured: baseline, 6 months
Change in alcohol and drug problems between baseline and 1 month
Self-reported frequency of alcohol and drugs problems in the past 30 days.
Measured: baseline, 1 month
Change in alcohol and drug problems between baseline and 3 months
Self-reported frequency of alcohol and drugs problems in the past 90 days.
Measured: baseline, 3 months
Change in alcohol and drug problems between baseline and 6 months
Self-reported frequency of alcohol and drugs problems in the past 180 days.
Measured: baseline, 6 months
Secondary outcomes (9)
Change in meeting attendance between baseline and 1 month
Frequency of 12-Step / peer-to-peer meetings attended in the past 30 days.
Measured: baseline, 1 month
Change in meeting attendance between baseline and 3 months
Frequency of 12-Step / peer-to-peer meetings attended in the past 90 days.
Measured: baseline, 3 months
Change in meeting attendance between baseline and 6 months
Frequency of 12-Step / peer-to-peer meetings attended in the past 180 days.
Measured: baseline, 6 months
Change in social network between baseline and 1 month
Proportion of social network that is sober in the past 30 days.
Measured: baseline, 1 month
Change in social network between baseline and 3 months
Proportion of social network that is sober in the past 90 days.
Measured: baseline, 3 months
Change in social network between baseline and 6 months
Proportion of social network that is sober in the past 180 days.
Measured: baseline, 6 months
Change in recovery related activities between baseline and 1 month
Frequency of engagement with recovery related activities during the past 30 days.
Measured: baseline, 1 month
Change in recovery related activities between baseline and 3 months
Frequency of engagement with recovery related activities during the past 90 days.
Measured: baseline, 3 months
Change in recovery related activities between baseline and 6 months
Frequency of engagement with recovery related activities during the past 180 days.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start9 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola Marymount University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Joseph LaBrie, Loyola Marymount University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042451
- Sponsor's protocol ID
- R44DA061662
- Status last verified
- Sep 2025
- First submitted
- 20 Jun 2025
- Last updated
- 11 Sep 2025
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Aftercare Assessed: An Evaluation of the Pink Cloud Application in Post-Treatment Substance Use Disorder Support
- ClinicalTrials.gov ID
- NCT07042451
- Acronym / sponsor ID
- R44DA061662
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,410 participants (estimated)
- Lead sponsor
- Loyola Marymount UniversityUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 29 Jun 2025 (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 randomized controlled trial (RCT) will evaluate the feasibility and efficacy of Pink Cloud, a mobile health application designed to support recovery from substance and alcohol use disorders (SUD/AUD). The app provides access to over 245,000 in-person and virtual 12-Step meetings, along with features such as a sobriety counter, daily planner, and personal inventory tools. In this study, 1,410 participants in various stages of recovery will be randomly assigned to receive either access to the Pink Cloud app or to a control condition. Participants will complete follow-up assessments at 1, 3, and 6 months. Primary outcomes include number of days sober and frequency of drug and alcohol problems. Secondary outcomes include meeting attendance, proportion of sober individuals in one's social network, and engagement in recovery-related activities. The investigators hypothesize that participants in the Pink Cloud group will report more days sober and fewer substance use problems than those in the control group, and that they will also report attending more meetings, having a greater proportion of sober peers, and engaging more frequently in recovery activities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pink Cloud | Experimental | Behavioral: Pink CloudParticipants in this arm will receive access to a mobile application designed to support ongoing recovery from substance and alcohol use disorders. The app includes tools that promote engagement with 12-Step recovery principles and offer self-monitoring features. Participants can integrate the app into their recovery efforts as they see fit throughout the study period. |
| Active Control | Active comparator | Behavioral: Active ControlParticipants in this arm will receive access to a website containing curated recovery-related materials. These resources are intended to offer general support for individuals in recovery, without emphasizing any specific program or approach. Participants are free to explore and use the content as they choose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is 18 years of age or older
- Participant is willing to attend a 12-Step or peer-to-peer recovery meeting (in person or virtual) within the next week
- Participant owns a personal smartphone with cellular service
- Participant is a permanent resident of the United States
- Participant feels comfortable reading and understanding written English in everyday situations
Key exclusion criteria (11 listed)
- Participant is younger than 18 years of age
- Participant is unwilling to attend a 12-Step or peer-to-peer recovery meeting (in person or virtual) within the next week
- Participant does not own a personal smartphone with cellular service
- Participant is not a permanent resident of the United States
- Participant does not feel comfortable reading and understanding written English in everyday situations
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 |
|---|---|---|
| Pink CloudParticipants randomized to the Pink Cloud condition will receive a subscription code to access the Pink Cloud mobile application for approximately 365 days. The app includes features such as a searchable database of over 245,000 12-Step meetings (in-person and virtual), a sobriety counter, customizable daily planners, personal inventory tools, and a resentment journal. Participants are encouraged to use the app as they see fit throughout the study period. No prompts or required usage schedules will be imposed; instead, engagement will be self-directed to reflect real-world usage patterns. | Behavioural | Pink Cloud |
| Active ControlParticipants randomized to the control condition will receive a code to access recovery-related resources hosted on a private study website. These materials include links to mutual-help groups, crisis support services, and educational content and treatment options. Participants may access the website at their discretion and engage with the resources as often and in whatever ways they choose. No prompts or required usage schedules will be imposed. | Behavioural | Active Control |
Primary outcome
Change in sobriety status between baseline and 1 month
Time frame: baseline, 1 month
Self-reported number of days participant reports not using alcohol or drugs in the past 30 days.
Change in sobriety status between baseline and 3 months
Time frame: baseline, 3 months
Self-reported number of days participant reports not using alcohol or drugs in the past 90 days.
Change in sobriety status between baseline and 6 months
Time frame: baseline, 6 months
Self-reported number of days participant reports not using alcohol or drugs in the past 180 days.
Change in alcohol and drug problems between baseline and 1 month
Time frame: baseline, 1 month
Self-reported frequency of alcohol and drugs problems in the past 30 days.
Change in alcohol and drug problems between baseline and 3 months
Time frame: baseline, 3 months
Self-reported frequency of alcohol and drugs problems in the past 90 days.
Change in alcohol and drug problems between baseline and 6 months
Time frame: baseline, 6 months
Self-reported frequency of alcohol and drugs problems in the past 180 days.
9 secondary outcomes
Change in meeting attendance between baseline and 1 month
Time frame: baseline, 1 month
Change in meeting attendance between baseline and 3 months
Time frame: baseline, 3 months
Change in meeting attendance between baseline and 6 months
Time frame: baseline, 6 months
Change in social network between baseline and 1 month
Time frame: baseline, 1 month
Change in social network between baseline and 3 months
Time frame: baseline, 3 months
Change in social network between baseline and 6 months
Time frame: baseline, 6 months
Change in recovery related activities between baseline and 1 month
Time frame: baseline, 1 month
Change in recovery related activities between baseline and 3 months
Time frame: baseline, 3 months
Change in recovery related activities between baseline and 6 months
Time frame: baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pink Cloud in people with Substance Use, run by Loyola Marymount University 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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph LaBrie, Ph.D. (3103385238, jlabrie@lmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sobriety status between baseline and 1 month (time frame: baseline, 1 month). The study lists 6 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 11 Sep 2025.