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NCT Number: NCT07042451

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.

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Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Informed consent is provided

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
  • Informed consent is not provided

Treatment and study plan

Pink Cloud

Behavioral

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 Control

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Change in meeting attendance between baseline and 1 month

    Time frame: baseline, 1 month

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

  2. Change in meeting attendance between baseline and 3 months

    Time frame: baseline, 3 months

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

  3. Change in meeting attendance between baseline and 6 months

    Time frame: baseline, 6 months

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

  4. Change in social network between baseline and 1 month

    Time frame: baseline, 1 month

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

  5. Change in social network between baseline and 3 months

    Time frame: baseline, 3 months

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

  6. Change in social network between baseline and 6 months

    Time frame: baseline, 6 months

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

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

    Time frame: baseline, 1 month

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

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

    Time frame: baseline, 3 months

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

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

    Time frame: baseline, 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph LaBrie, Ph.D.

CONTACT

[email protected]

3103385238

Sponsors and collaborators

Lead sponsor

Loyola Marymount University

Other

Registry information

Official study title

Digital Aftercare Assessed: An Evaluation of the Pink Cloud Application in Post-Treatment Substance Use Disorder Support

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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