ClinicalTrials.gg
RecruitingNCT07042451Updated Sep 11, 2025

An Evaluation of the Pink Cloud Application in Post- Treatment Substance Use Disorder Support

An interventional study of Pink Cloud and Active Control in Substance Use, sponsored by Loyola Marymount University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Loyola Marymount University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,410
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Substance Use
03

In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's planned enrollment of 1,410 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Loyola Marymount University is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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.
  • is provided

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
  • is not provided
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,410 participants (estimated)

Study arms

  • Experimental
    Pink Cloud

    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.

    Behavioral: Pink Cloud

  • Active comparator
    Active Control

    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.

    Behavioral: Active Control

Interventions

  • BehavioralPink Cloud

    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.

  • BehavioralActive Control

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 1 month

  2. 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.

    Time frame: baseline, 3 months

  3. 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.

    Time frame: baseline, 6 months

  4. Change in alcohol and drug problems between baseline and 1 month

    Self-reported frequency of alcohol and drugs problems in the past 30 days.

    Time frame: baseline, 1 month

  5. Change in alcohol and drug problems between baseline and 3 months

    Self-reported frequency of alcohol and drugs problems in the past 90 days.

    Time frame: baseline, 3 months

  6. Change in alcohol and drug problems between baseline and 6 months

    Self-reported frequency of alcohol and drugs problems in the past 180 days.

    Time frame: baseline, 6 months

Secondary outcomes

  1. Change in meeting attendance between baseline and 1 month

    Frequency of 12-Step / peer-to-peer meetings attended in the past 30 days.

    Time frame: baseline, 1 month

  2. Change in meeting attendance between baseline and 3 months

    Frequency of 12-Step / peer-to-peer meetings attended in the past 90 days.

    Time frame: baseline, 3 months

  3. Change in meeting attendance between baseline and 6 months

    Frequency of 12-Step / peer-to-peer meetings attended in the past 180 days.

    Time frame: baseline, 6 months

  4. Change in social network between baseline and 1 month

    Proportion of social network that is sober in the past 30 days.

    Time frame: baseline, 1 month

  5. Change in social network between baseline and 3 months

    Proportion of social network that is sober in the past 90 days.

    Time frame: baseline, 3 months

  6. Change in social network between baseline and 6 months

    Proportion of social network that is sober in the past 180 days.

    Time frame: baseline, 6 months

  7. Change in recovery related activities between baseline and 1 month

    Frequency of engagement with recovery related activities during the past 30 days.

    Time frame: baseline, 1 month

  8. Change in recovery related activities between baseline and 3 months

    Frequency of engagement with recovery related activities during the past 90 days.

    Time frame: baseline, 3 months

  9. Change in recovery related activities between baseline and 6 months

    Frequency of engagement with recovery related activities during the past 180 days.

    Time frame: baseline, 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07042451
Lead sponsor
Loyola Marymount University
Responsible party
Dr. Joseph LaBrie (Principal Investigator, Loyola Marymount University) — Principal investigator
First posted
Jun 29, 2025
Start date
Jul 9, 2025
Primary completion
Jul 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Sep 11, 2025

Study contacts

Joseph LaBrie, Ph.D.
Contact
jlabrie@lmu.edu
3103385238

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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