Protocol summary
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Study aim
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To examine the effectiveness of a newly designed, culturally adapted, gender-sensitive, smartphone-based intervention based on a community-based reinforcement approach, motivational interviewing, and cognitive-behavioral therapy in patients undergoing opioid maintenance treatment with methadone and buprenorphine in Iran.
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Design
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After a detailed gender-sensitive iterative pilot and validation process, the final PROMPT version (Study arm 1) will be compared with OAT as usual (Study arm 2) in a randomized controlled trial (RCT) within 400 opioid-dependent patients at eight treatment centers.
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Settings and conduct
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Patients in the 8 addiction treatment center in Tehran who are under the treatment, were randomly assigned to the intervention group (OAT+smartphone intervention) and control group (OAT) based on the designed protocol.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
To provide written informed consent;
Minimal age of 18 years;
Positive urine test for morphine or tramadol;
Diagnosis of opioid dependence (ICD-11);
Stabilization on methadone or buprenorphine for at least 2 weeks and maximum 8 weeks;
Ownership of a smartphone;
Internet access;
Good command of Persian;
Appropriate geographical access to the study site in Tehran.
Exclusion Criteria:
Concurrent dependence on other substances (except nicotine);
Current severe or acute psychiatric diseases.
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Intervention groups
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The intervention group will receive an integrated Community Reinforcement Approach, motivational interviewing, and CBT-based guided smartphone intervention (PROMPT) added to OAT as usual.
The control group will receive OAT as usual, as in the intervention group, but without the smartphone intervention.
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Main outcome variables
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1-Percentage of negative urine tests for illicit, non-prescribed use of opioids
2- Retention in treatment and study
General information
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Reason for update
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Change planning for implementation
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170702034844N8
Registration date:
2021-02-21, 1399/12/03
Registration timing:
prospective
Last update:
2025-12-22, 1404/10/01
Update count:
2
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Registration date
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2021-02-21, 1399/12/03
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2025-12-23, 1404/10/02
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Expected recruitment end date
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2026-12-23, 1405/10/02
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Guided smartphone-based treatment for patients in opioid maintenance treatment in Iran - transdiagnostic treatment for substance use and common mental disorders
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Public title
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Guided smartphone-based treatment for patients in opioid maintenance treatmen
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Written informed consent
Minimal age of 18 years
Stabilization on methadone or buprenorphine dosage for at least 2 weeks and a maximum of 8 weeks
Ownership of a smartphone
Good command of Persian
Appropriate geographical access to the study site in Tehran
Internet access
Positive urine test for morphine or tramadol
Opioid dependence based on ICD-11
Exclusion criteria:
Diagnosis of concurrent dependence on other substances (except nicotine)
Current severe or acute psychiatric disorders.
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
400
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants, after completing baseline assessment, will be randomized by an automated computer program into either the treatment or control group in a 1:1 ratio.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-03, 1399/08/13
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1399.714
Health conditions studied
1
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Description of health condition studied
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Moderate to severe opioids use disorder
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ICD-10 code
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F11.2
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ICD-10 code description
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Opioid dependence
Primary outcomes
1
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Description
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The percentage of negative urine tests for illicit, non-prescribed use of opioids
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Timepoint
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Baseline and months 1 to 12
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Method of measurement
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Urine rapid test
2
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Description
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Retention in treatment and study
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Timepoint
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Months 1, 2, 3, 6, and 12
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Method of measurement
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Self-report and treatment record
Secondary outcomes
1
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Description
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Days of opioid use during last 7 days
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Timepoint
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Baseline and months 1 to 12
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Method of measurement
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Self-report Timeline Follow Back Questionnaire
2
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Description
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Days of street-drug use during last 7 days
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Timepoint
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Baseline and months 1 to 12
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Method of measurement
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Self-report TLFB Questionnaire
3
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Description
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Severity of opioid dependence
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Timepoint
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Baseline and months 1, 2, 3, 6 and 12
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Method of measurement
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Rapid urine test
4
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Description
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The longest period of abstinence from the illicit opioids
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Timepoint
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Months 1, 2 and 3
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Method of measurement
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Urine rapid test
5
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Description
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Score of communicable disease risk-taking behaviors
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Timepoint
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At the baseline and 3-, 6- and 12-month follow-up.
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Method of measurement
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Blood-borne Virus Transmission Risk Assessment Questionnaire BBV-TRAQ
6
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Description
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Score of perceived stress
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Timepoint
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At the baseline and 3-, 6- and 12-month follow-up.
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Method of measurement
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Perceived Stress Scale
7
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Description
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Score of depression
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Timepoint
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At the baseline and 3-, 6- and 12-month follow-up
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Method of measurement
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Patient Health Questionnaire
8
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Description
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Score of anxiety
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Timepoint
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At the baseline and 3-, 6- and 12-month follow-up
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Method of measurement
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Generalized Anxiety Disorder Questionnaire
9
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Description
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Score of Trauma
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Timepoint
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At the baseline and 3-, 6- and 12-month follow-up
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Method of measurement
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International Trauma Questionnaire for PTSD
10
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Description
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Score of Alcohol Use Disorder
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Timepoint
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At the baseline and 3-, 6- and 12-month follow-up
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Method of measurement
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Alcohol Use Disorder Identification Test (AUDIT-C Questionnaire)
11
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Description
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Score of Nicotine Dependence
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Timepoint
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At the baseline and 3-, 6- and 12-month follow-up
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Method of measurement
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Fagerstrom Test for Nicotine Dependence Questionnaire
12
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Description
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Number of missed OAT appointments
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Timepoint
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Months 1, 2, 3, 6 and 12
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Method of measurement
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Physician report
13
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Description
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Score of Client Satisfaction
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Timepoint
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Months 1, 2, 3, 6 and 12
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Method of measurement
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Client Satisfaction Questionnaire
14
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Description
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Score of psychological treatment negative effects
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Timepoint
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Months 1, 2, 3, 6 and 12
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Method of measurement
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Negative Effects Questionnaire
15
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Description
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HIV results test
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Timepoint
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At the baseline and 3-, 6- and 12-month follow-up
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Method of measurement
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Blood Test
Intervention groups
1
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Description
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Intervention group: The intervention group will receive an integrated community reinforcement approach, motivational interviewing, and cognitive, behavioral treatment-based guided smartphone intervention (called PROMPT for Promoting Recovery in Opioid Maintenance and Psychosocial Treatments) added to opioid maintenance treatment (OMT).
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Category
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Behavior
2
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Description
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Control group: Control group will receive opioid maintenance treatment with methadone or buprenorphine based on national protocols.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Swiss National Science Foundation
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Foreign
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Category of foreign source of funding
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Sponsor: country of origin
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Country of origin
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CH
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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It is planned to share IPD, study protocol and report of the clinical study.
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When the data will become available and for how long
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IPD will be shared after completion of the data gathering phase. Study protocol will be available within 3 months after successful registration of the trial. Report of the clinical study will be finalized at the end of study
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To whom data/document is available
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Clinical researchers
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Under which criteria data/document could be used
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IPD will be available for researchers who are conducting review studies. The study protocol and report will be published as English articles.
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From where data/document is obtainable
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Email to the individual who is responsible for scientific inquiries of this project
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What processes are involved for a request to access data/document
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It will be responded after processing within the project team.
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Comments
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