Opioid-use DisorderNCT05047627
Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
A study testing Smartphone-Based Digital Intervention in people with Opioid-use Disorder and Anxiety Disorders, run by Trustees of Dartmouth College at 1 site in United States.
Trial summary
The majority of opioid users meet criteria for anxiety and depressive disorders, but most substance use disorder treatment programs do not offer treatment for co-occurring mental health problems. Anxiety and depression may also be directly linked to opioid use itself. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Anxiety Disorders, Depressive Disorder
- What is being tested?
- Smartphone-Based Digital Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults (age 18 or older)
- fluent in English
- able to provide informed consent
- meet current criteria for OUD (as defined by a Rapid Opioid Dependence Screen)
- are receiving methadone, buprenorphine, and/or naltrexone for OUD
- meet current criteria for an anxiety and/or depressive disorder (based on the Patient Health Questionnaire and the Generalized Anxiety Disorder Questionnaire).
Who cannot join
- active suicidality
- psychosis
- bipolar disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Center For Technology and Behavioral Health
Lebanon, New Hampshire, 03766
About this study
The majority of opioid users meet criteria for anxiety and depressive disorders, but most substance use disorder treatment programs do not offer treatment for co-occurring mental health problems. Anxiety and depression may also be directly linked to opioid use itself. Although treatments have been developed for anxiety and depressive symptoms for opioid users within face-to-face settings, few treatment facilities offer these in-person interventions due to their high cost and time burden. Given the deficits in research on treatments for anxiety and depression among those with opioid use disorder, the current research will examine the efficacy of a digital intervention designed to treat anxiety and depressive symptoms by augmenting the state of the science medication-based opioid use disorder treatment. Over the course of the proposed study, the research team will design and test the feasibility and acceptability of a standalone mobile intervention designed to treat persons receiving medication treatment for opioid use disorder. Participants receiving medication treatment for opioid use disorder will be randomized to receive a digital intervention to treat anxiety and depression or care as usual for a total of four weeks. The overarching goal of the proposed work is to test the feasibility and acceptability of the proposed mobile intervention. The Investigators will also explore the preliminary efficacy by examining reductions in anxiety and depressive symptoms and opioid cravings and use. This work could lead to a low-cost scalable solution to augment gold-standard treatment as usual in opioid use disorder by decreasing levels of comorbidity of anxiety and depressive disorders, thereby ultimately improving the outcomes of opioid use disorder itself.
Read the detailed description
The study team will recruit a population of 60 adults who are receiving medication treatment for OUD from an online study based on Google Adwords, Reddit, and Facebook advertisements as online recruitment has been shown to be a viable and cost-effective recruitment method for opioid users. The total sample size may be expanded if recruitment costs are lower than expected.
Participants will complete self-report assessments on their anxiety symptoms, depressive symptoms, opioid cravings, and opioid use behaviors. Participants will be randomized to a smartphone-based digital intervention or waitlist control condition. The digital intervention will be designed to treat participants' anxiety and depressive symptoms, and participants will be asked to use the intervention four times per week for four weeks (16 digital sessions).The smartphone intervention will also collect passive sensing data continuously during the 4 week period. Participants will complete post measures and one-month follow-up measures on anxiety symptoms, depressive symptoms, opioid cravings, and opioid use behaviors. The urine drug screen will be mailed to participants. Participants will also be asked to complete five urine tests to detect substance use (amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, marijuana, methamphetamine, opioids, oxycodone, and pcp) across the study (1 at pre-digital intervention, 1 during the digital intervention, 1 post-digital intervention, 1 between post and follow-up of the digital intervention, and 1 at the 1-month follow-up of the digital intervention). Participants will be instructed when to complete each urine test and will be asked to take a photo of the back the label of each test showing the results to the experimenters and to text these photos to a Google Voice Number maintained by the experimenters.
Thus, this proposal seeks to address a crucial deficit in the availability of treatments for anxiety and depressive disorders among persons with OUD to ultimately augment treatment for OUD.
- Conditions
- Opioid-use Disorder, Anxiety Disorders, Depressive Disorder
- Being tested
- Smartphone-Based Digital Intervention
- Medical subject headings
- Opioid-Related Disorders, Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-Based Digital InterventionBehavioural
The digital intervention will be a prototype, and the current trial will be used to continue to both develop and refine the intervention. The current intervention will be based on a combination of cognitive-behavioral principles. As with prior research, the mobile platform will be delivered via Qualtrics, a HIPAA compliant and mobile-friendly platform. The cognitive-behavioral therapy will be primarily based on components with strongest support in digital interventions. The app will continuously collect passive sensing data on patterns in 1) sleep duration and quality;(2) light (3) location; (4) movement (5) social contact including duration and frequency of incoming and outcoming calls and text messages; (6) screen time; and (7) heart rate variability; (8) sound levels captured through passively collected smartphone The platform will deliver interactive interventions where participants will view texts and images, and it will also allow user interaction.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Digital Intervention Group | Experimental | The Smartphone Digital Intervention Group is the experimental group. Participants randomized to this group will download the smartphone intervention and be asked to use the intervention four times per week for four weeks ( 16 digital sessions). The smartphone digital intervention will also continuously collect passive sensing data. The smartphone digital intervention will be designed to treat anxiety and depression by providing informational videos to help participants treat these symptoms. These videos include information about physical activity, muscle relaxation, and other proven helpful interventions to help with anxiety and depression. Receives: Behavioral: Smartphone-Based Digital Intervention |
| Wait list Control Condition | No intervention | The wait list control condition will not receive the digital intervention treatment for the duration of the study. They will still provide urine samples during the study. Participants assigned to this condition will be able to access the digital intervention after their participation in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale
Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
Measured: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9
Assesses depressive symptoms, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day)
Measured: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Change in Likelihood of a Positive Urine Screen for Opioids (MOP)
This outcome measures the change in the likelihood of a positive urine drug screen (UDS) for opioids (MOP). The result of each UDS was coded as a binary variable (0 = negative test, 1 = positive test). The reported data are the beta coefficients (estimated mean change) from a robust linear mixed-effects model, which are presented on a unitless scale. A negative value indicates a reduction in the likelihood of testing positive and represents a better outcome.
Measured: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Secondary outcomes (2)
Change in Opioid Use Disorder Severity as Measured by the Rapid Opioid Dependence Screen (RODS)
The Rapid Opioid Dependence Screen (RODS) is an 8-item measure used to assess opioid dependence severity. For this study, a total score was calculated by summing two components: 1) The number of endorsed opioid types from Item 1 (which lists 8 types, range 0-8), and 2) The number of "yes" responses to the 7 dependence-related questions in Items 2-8 (range 0-7). This method results in a total possible score range of 0 to 15. Higher scores indicate a greater breadth of lifetime opioid use and a higher number of dependence symptoms. A reduction in score represents improvement.
Measured: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Change in Opioid Craving as Measured by the Opioid Craving Scale (OCS)
Opioid Craving Scale (OCS) is a 3-item self-report measure used to assess opioid craving. Each of the three items is rated on a scale from 0 to 9. The total score is calculated by taking the average of the three item scores, resulting in a final score range of 0 to 9. Higher scores indicate a greater severity of craving. A reduction in score represents improvement.
Measured: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start15 Sep 2021
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (34)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Jacobson, Trustees of Dartmouth College
- Investigators
- Nicholas C Jacobson, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047627
- Sponsor's protocol ID
- AWD00010555
- Status last verified
- Oct 2025
- First submitted
- 13 Aug 2021
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Applebaum AJ, Bullis JR, Traeger LN, O'cleirigh C, Otto MW, Pollack MH, Safren SA. Rates of mood and anxiety disorders and contributors to continued heroin use in methadone maintenance patients: A comparison by HIV status. Neurobehav HIV Med. 2010 Aug 10;2010(2):49-57. doi: 10.2147/NBHIV.S12371.
PubMed 24062619Barry DT, Beitel M, Breuer T, Cutter CJ, Savant J, Peters S, Schottenfeld RS, Rounsaville BJ. Group-based strategies for stress reduction in methadone maintenance treatment: what do patients want? J Addict Med. 2011 Sep;5(3):181-7. doi: 10.1097/ADM.0b013e3181ee77cl.
PubMed 21841430Bartoli F, Carra G, Brambilla G, Carretta D, Crocamo C, Neufeind J, Baldacchino A, Humphris G, Clerici M. Association between depression and non-fatal overdoses among drug users: a systematic review and meta-analysis. Drug Alcohol Depend. 2014 Jan 1;134:12-21. doi: 10.1016/j.drugalcdep.2013.10.007. Epub 2013 Oct 24.
PubMed 24210424Blume, A. W., Schmaling, K. B., & Marlatt, G. A. (2000). Revisiting the self-medication hypothesis from a behavioral perspective. Cognitive and Behavioral Practice, 7(4), 379-384. https://doi.org/10.1016/S1077-7229(00)80048-6
Borkovec TD, Newman MG, Pincus AL, Lytle R. A component analysis of cognitive-behavioral therapy for generalized anxiety disorder and the role of interpersonal problems. J Consult Clin Psychol. 2002 Apr;70(2):288-98.
PubMed 11952187Childress AR, Ehrman R, McLellan AT, MacRae J, Natale M, O'Brien CP. Can induced moods trigger drug-related responses in opiate abuse patients? J Subst Abuse Treat. 1994 Jan-Feb;11(1):17-23. doi: 10.1016/0740-5472(94)90060-4.
PubMed 8201629Cunningham JA, Hendershot CS, Kay-Lambkin F, Neighbors C, Griffiths KM, Bennett K, Bennett A, Godinho A, Schell C. Does providing a brief internet intervention for hazardous alcohol use to people seeking online help for depression reduce both alcohol use and depression symptoms among participants with these co-occurring disorders? Study protocol for a randomised controlled trial. BMJ Open. 2018 Jul 19;8(7):e022412. doi: 10.1136/bmjopen-2018-022412.
PubMed 30030322Deady M, Mills KL, Teesson M, Kay-Lambkin F. An Online Intervention for Co-Occurring Depression and Problematic Alcohol Use in Young People: Primary Outcomes From a Randomized Controlled Trial. J Med Internet Res. 2016 Mar 23;18(3):e71. doi: 10.2196/jmir.5178.
PubMed 27009465Firth J, Torous J, Nicholas J, Carney R, Pratap A, Rosenbaum S, Sarris J. The efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials. World Psychiatry. 2017 Oct;16(3):287-298. doi: 10.1002/wps.20472.
PubMed 28941113Firth J, Torous J, Nicholas J, Carney R, Rosenbaum S, Sarris J. Can smartphone mental health interventions reduce symptoms of anxiety? A meta-analysis of randomized controlled trials. J Affect Disord. 2017 Aug 15;218:15-22. doi: 10.1016/j.jad.2017.04.046. Epub 2017 Apr 25.
PubMed 28456072Hassan AN, Howe AS, Samokhvalov AV, Le Foll B, George TP. Management of mood and anxiety disorders in patients receiving opioid agonist therapy: Review and meta-analysis. Am J Addict. 2017 Sep;26(6):551-563. doi: 10.1111/ajad.12581. Epub 2017 Jul 4.
PubMed 28675762Hogarth L, Hardy L, Bakou A, Mahlberg J, Weidemann G, Cashel S, Moustafa AA. Negative Mood Induction Increases Choice of Heroin Versus Food Pictures in Opiate-Dependent Individuals: Correlation With Self-Medication Coping Motives and Subjective Reactivity. Front Psychiatry. 2019 May 15;10:274. doi: 10.3389/fpsyt.2019.00274. eCollection 2019.
PubMed 31156470Hyman SM, Fox H, Hong KI, Doebrick C, Sinha R. Stress and drug-cue-induced craving in opioid-dependent individuals in naltrexone treatment. Exp Clin Psychopharmacol. 2007 Apr;15(2):134-43. doi: 10.1037/1064-1297.15.2.134.
PubMed 17469937Kay-Lambkin FJ, Baker AL, Lewin TJ, Carr VJ. Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: a randomized controlled trial of clinical efficacy. Addiction. 2009 Mar;104(3):378-88. doi: 10.1111/j.1360-0443.2008.02444.x.
PubMed 19207345Kenardy JA, Dow MG, Johnston DW, Newman MG, Thomson A, Taylor CB. A comparison of delivery methods of cognitive-behavioral therapy for panic disorder: an international multicenter trial. J Consult Clin Psychol. 2003 Dec;71(6):1068-75. doi: 10.1037/0022-006X.71.6.1068.
PubMed 14622082
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05047627
- Acronym / sponsor ID
- AWD00010555
- Conditions
- Opioid-use Disorder, Anxiety Disorders, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Posted 5 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The majority of opioid users meet criteria for anxiety and depressive disorders, but most substance use disorder treatment programs do not offer treatment for co-occurring mental health problems. Anxiety and depression may also be directly linked to opioid use itself. Although treatments have been developed for anxiety and depressive symptoms for opioid users within face-to-face settings, few treatment facilities offer these in-person interventions due to their high cost and time burden. Given the deficits in research on treatments for anxiety and depression among those with opioid use disorder, the current research will examine the efficacy of a digital intervention designed to treat anxiety and depressive symptoms by augmenting the state of the science medication-based opioid use disorder treatment. Over the course of the proposed study, the research team will design and test the feasibility and acceptability of a standalone mobile intervention designed to treat persons receiving medication treatment for opioid use disorder. Participants receiving medication treatment for opioid use disorder will be randomized to receive a digital intervention to treat anxiety and depression or care as usual for a total of four weeks. The overarching goal of the proposed work is to test the feasibility and acceptability of the proposed mobile intervention. The Investigators will also explore the preliminary efficacy by examining reductions in anxiety and depressive symptoms and opioid cravings and use. This work could lead to a low-cost scalable solution to augment gold-standard treatment as usual in opioid use disorder by decreasing levels of comorbidity of anxiety and depressive disorders, thereby ultimately improving the outcomes of opioid use disorder itself.
Detailed description
The study team will recruit a population of 60 adults who are receiving medication treatment for OUD from an online study based on Google Adwords, Reddit, and Facebook advertisements as online recruitment has been shown to be a viable and cost-effective recruitment method for opioid users. The total sample size may be expanded if recruitment costs are lower than expected.
Participants will complete self-report assessments on their anxiety symptoms, depressive symptoms, opioid cravings, and opioid use behaviors. Participants will be randomized to a smartphone-based digital intervention or waitlist control condition. The digital intervention will be designed to treat participants' anxiety and depressive symptoms, and participants will be asked to use the intervention four times per week for four weeks (16 digital sessions).The smartphone intervention will also collect passive sensing data continuously during the 4 week period. Participants will complete post measures and one-month follow-up measures on anxiety symptoms, depressive symptoms, opioid cravings, and opioid use behaviors. The urine drug screen will be mailed to participants. Participants will also be asked to complete five urine tests to detect substance use (amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, marijuana, methamphetamine, opioids, oxycodone, and pcp) across the study (1 at pre-digital intervention, 1 during the digital intervention, 1 post-digital intervention, 1 between post and follow-up of the digital intervention, and 1 at the 1-month follow-up of the digital intervention). Participants will be instructed when to complete each urine test and will be asked to take a photo of the back the label of each test showing the results to the experimenters and to text these photos to a Google Voice Number maintained by the experimenters.
Thus, this proposal seeks to address a crucial deficit in the availability of treatments for anxiety and depressive disorders among persons with OUD to ultimately augment treatment for OUD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone Digital Intervention Group | Experimental | Behavioral: Smartphone-Based Digital InterventionThe Smartphone Digital Intervention Group is the experimental group. Participants randomized to this group will download the smartphone intervention and be asked to use the intervention four times per week for four weeks ( 16 digital sessions). The smartphone digital intervention will also continuously collect passive sensing data. The smartphone digital intervention will be designed to treat anxiety and depression by providing informational videos to help participants treat these symptoms. These videos include information about physical activity, muscle relaxation, and other proven helpful interventions to help with anxiety and depression. |
| Wait list Control Condition | No intervention | –The wait list control condition will not receive the digital intervention treatment for the duration of the study. They will still provide urine samples during the study. Participants assigned to this condition will be able to access the digital intervention after their participation in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (age 18 or older)
- fluent in English
- able to provide informed consent
- meet current criteria for OUD (as defined by a Rapid Opioid Dependence Screen)
- are receiving methadone, buprenorphine, and/or naltrexone for OUD
Key exclusion criteria (3 listed)
- active suicidality
- psychosis
- bipolar disorder
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 |
|---|---|---|
| Smartphone-Based Digital InterventionThe digital intervention will be a prototype, and the current trial will be used to continue to both develop and refine the intervention. The current intervention will be based on a combination of cognitive-behavioral principles. As with prior research, the mobile platform will be delivered via Qualtrics, a HIPAA compliant and mobile-friendly platform. The cognitive-behavioral therapy will be primarily based on components with strongest support in digital interventions. The app will continuously collect passive sensing data on patterns in 1) sleep duration and quality;(2) light (3) location; (4) movement (5) social contact including duration and frequency of incoming and outcoming calls and text messages; (6) screen time; and (7) heart rate variability; (8) sound levels captured through passively collected smartphone The platform will deliver interactive interventions where participants will view texts and images, and it will also allow user interaction. | Behavioural | Smartphone Digital Intervention Group |
Primary outcome
Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale
Time frame: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9
Time frame: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Assesses depressive symptoms, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day)
Change in Likelihood of a Positive Urine Screen for Opioids (MOP)
Time frame: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
This outcome measures the change in the likelihood of a positive urine drug screen (UDS) for opioids (MOP). The result of each UDS was coded as a binary variable (0 = negative test, 1 = positive test). The reported data are the beta coefficients (estimated mean change) from a robust linear mixed-effects model, which are presented on a unitless scale. A negative value indicates a reduction in the likelihood of testing positive and represents a better outcome.
2 secondary outcomes
Change in Opioid Use Disorder Severity as Measured by the Rapid Opioid Dependence Screen (RODS)
Time frame: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Change in Opioid Craving as Measured by the Opioid Craving Scale (OCS)
Time frame: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24062619Applebaum AJ, Bullis JR, Traeger LN, O'cleirigh C, Otto MW, Pollack MH, Safren SA. Rates of mood and anxiety disorders and contributors to continued heroin use in methadone maintenance patients: A comparison by HIV status. Neurobehav HIV Med. 2010 Aug 10;2010(2):49-57. doi: 10.2147/NBHIV.S12371.
- Background: PubMed 21841430Barry DT, Beitel M, Breuer T, Cutter CJ, Savant J, Peters S, Schottenfeld RS, Rounsaville BJ. Group-based strategies for stress reduction in methadone maintenance treatment: what do patients want? J Addict Med. 2011 Sep;5(3):181-7. doi: 10.1097/ADM.0b013e3181ee77cl.
- Background: PubMed 24210424Bartoli F, Carra G, Brambilla G, Carretta D, Crocamo C, Neufeind J, Baldacchino A, Humphris G, Clerici M. Association between depression and non-fatal overdoses among drug users: a systematic review and meta-analysis. Drug Alcohol Depend. 2014 Jan 1;134:12-21. doi: 10.1016/j.drugalcdep.2013.10.007. Epub 2013 Oct 24.
- BackgroundBlume, A. W., Schmaling, K. B., & Marlatt, G. A. (2000). Revisiting the self-medication hypothesis from a behavioral perspective. Cognitive and Behavioral Practice, 7(4), 379-384. https://doi.org/10.1016/S1077-7229(00)80048-6
- Background: PubMed 11952187Borkovec TD, Newman MG, Pincus AL, Lytle R. A component analysis of cognitive-behavioral therapy for generalized anxiety disorder and the role of interpersonal problems. J Consult Clin Psychol. 2002 Apr;70(2):288-98.
- Background: PubMed 8201629Childress AR, Ehrman R, McLellan AT, MacRae J, Natale M, O'Brien CP. Can induced moods trigger drug-related responses in opiate abuse patients? J Subst Abuse Treat. 1994 Jan-Feb;11(1):17-23. doi: 10.1016/0740-5472(94)90060-4.
- Background: PubMed 30030322Cunningham JA, Hendershot CS, Kay-Lambkin F, Neighbors C, Griffiths KM, Bennett K, Bennett A, Godinho A, Schell C. Does providing a brief internet intervention for hazardous alcohol use to people seeking online help for depression reduce both alcohol use and depression symptoms among participants with these co-occurring disorders? Study protocol for a randomised controlled trial. BMJ Open. 2018 Jul 19;8(7):e022412. doi: 10.1136/bmjopen-2018-022412.
- Background: PubMed 27009465Deady M, Mills KL, Teesson M, Kay-Lambkin F. An Online Intervention for Co-Occurring Depression and Problematic Alcohol Use in Young People: Primary Outcomes From a Randomized Controlled Trial. J Med Internet Res. 2016 Mar 23;18(3):e71. doi: 10.2196/jmir.5178.
- Background: PubMed 28941113Firth J, Torous J, Nicholas J, Carney R, Pratap A, Rosenbaum S, Sarris J. The efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials. World Psychiatry. 2017 Oct;16(3):287-298. doi: 10.1002/wps.20472.
- Background: PubMed 28456072Firth J, Torous J, Nicholas J, Carney R, Rosenbaum S, Sarris J. Can smartphone mental health interventions reduce symptoms of anxiety? A meta-analysis of randomized controlled trials. J Affect Disord. 2017 Aug 15;218:15-22. doi: 10.1016/j.jad.2017.04.046. Epub 2017 Apr 25.
- Background: PubMed 28675762Hassan AN, Howe AS, Samokhvalov AV, Le Foll B, George TP. Management of mood and anxiety disorders in patients receiving opioid agonist therapy: Review and meta-analysis. Am J Addict. 2017 Sep;26(6):551-563. doi: 10.1111/ajad.12581. Epub 2017 Jul 4.
- Background: PubMed 31156470Hogarth L, Hardy L, Bakou A, Mahlberg J, Weidemann G, Cashel S, Moustafa AA. Negative Mood Induction Increases Choice of Heroin Versus Food Pictures in Opiate-Dependent Individuals: Correlation With Self-Medication Coping Motives and Subjective Reactivity. Front Psychiatry. 2019 May 15;10:274. doi: 10.3389/fpsyt.2019.00274. eCollection 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nicholas C Jacobson, PhD principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-Based Digital Intervention in people with Opioid-use Disorder and Anxiety Disorders, run by Trustees of Dartmouth College 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 6 inclusion and 3 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 5 Nov 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?
Yes. Results are posted in the registry (first posted 5 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale (time frame: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05047627, which also lists 34 linked publications.
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 5 Nov 2025.