]>
IRCT20210804052079N1 IRCT 2022-06-02 Institute for Cognitive Science Studies Effect of CIREF on craving and delay discounting in people with opioid use disorder receiving methadone treatment. CIREF A Pilot Study of Cue-Exposure Combined with Episodic Future Thinking (CIREF) Intervention on Craving and Delay Discounting in Opioid Users Receiving Methadone Maintenance Treatment. 2022-06-06 anticipated 28 Complete https://irct.ir/trial/63846 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This pilot study provides the first empirical evaluation of Cue-Induced Reconsolidation and Episodic Future Thinking (CIREF), a manualized intervention integrating personalized drug-cue exposure, memory reactivation, and episodic future thinking. Participants completed one screening and personalized cue-development session followed by three 75-minute intervention sessions. Six individualized opioid-related cues were selected for each participant based on ratings of arousal, salience, valence, and vividness and were used throughout the intervention. The active control condition, Episodic Recent Thinking (ERT), followed a comparable structure while using recent-past rather than future-oriented episodic processing, Randomization description: After screening and informed consent, eligible participants were randomly allocated in a 1:1 ratio to the CIREF or ERT group using computer-generated block randomization with a fixed block size of four, applied independently at each recruitment site. Each block contained two CIREF and two ERT assignments, with one of the six possible balanced permutations selected randomly. The allocation sequence was generated in Python by a statistician who was not involved in recruitment, enrollment, or intervention delivery. Allocation concealment was maintained using sequentially numbered assignment codes, Blinding description: Due to the experiential nature of the interventions—future-oriented episodic simulation in CIREF and recent-past episodic retrieval in ERT—participants could not be blinded to their assigned condition. However, participants were not informed which condition was considered the experimental intervention or active control, and they were not informed of the study hypotheses. The intervention providers were aware of group allocation because this was necessary to deliver the condition-specific procedures. Clinic staff involved in participants’ routine clinical care, including nurses, psychologists, assistants, and the clinic technical manager, remained blinded to group allocation. N/A Opioid Substance Use. Intervention 1: Participants in the CIREF group completed three 75-minute intervention sessions following baseline assessment and personalized cue development. Six individualized opioid-related cues were selected for future time intervals (1 day, 1 week, 1 month, 3 months, 6 months, and 1 year). In each session, cue exposure was followed by four stages of episodic future thinking: (1) simulation of a future cue-related event, (2) prediction and appraisal of possible responses and outcomes, (3) formation of a specific adaptive intention or goal, and (4) development of concrete action plans. Phasic craving (DDQ) was assessed before and after each session, while tonic craving (OCDUS) and delay discounting (MCQ) were assessed before and after the intervention period. Intervention 2: Participants in the ERT active control group completed the same intervention dose, session structure, cue-exposure procedures, and therapist-guided exercises as the CIREF group. Six individualized opioid-related cues were linked to recent-past intervals (1, 2, 3, 5, 7, and 9 days earlier). Each cue was followed by episodic retrieval of a recent-past event, prediction and appraisal of responses and outcomes, intention formation, and planning. The main difference from CIREF was temporal orientation: past-oriented retrieval in ERT versus future-oriented simulation in CIREF. DDQ was assessed before and after each session, while OCDUS and MCQ were assessed before and after the intervention period. Yes - There is a plan to make this available What will be shared: De-identified participant-level dataset and supporting analysis materials for the CIREF pilot randomized controlled trial. Details: De-identified participant-level data used in the reported analyses may be shared upon reasonable request, including demographic and clinical variables, cue ratings, treatment-group assignment, DDQ, OCDUS, and MCQ outcomes, together with relevant derived variables, a data dictionary, and statistical analysis code. Direct identifiers and potentially identifying free-text information, including personalized cue content, will not be shared. When: The de-identified participant-level data and supporting materials will be available upon reasonable request after publication of the primary study results. There is no predetermined end date for data availability; requests may be submitted for as long as the study team is able to maintain and securely share the data. To whom: De-identified participant-level data and supporting documents may be shared, upon reasonable request, with qualified researchers from academic, clinical, governmental, or other legitimate research institutions. Requests from researchers outside academia may also be considered if the proposed use is scientifically appropriate and consistent with ethical and confidentiality requirements. Conditions: De-identified participant-level data and supporting materials may be used for scientifically appropriate secondary analyses, replication and reproducibility studies, meta-analyses, methodological research, or related academic purposes. Requests should describe the research question, planned analyses, investigators, and data-security procedures. Requests will be reviewed by the corresponding author and study team for scientific appropriateness, ethical acceptability, participant confidentiality, and feasibility. Approved users may be required to sign a data-use agreement and must not attempt to re-identify participants. Where to obtain: The de-identified participant-level data and supporting documents may be requested from the corresponding author, Dr. Tara Rezapour, Department of Cognitive Psychology, Institute for Cognitive Science Studies (ICSS), Tehran, Iran, by email at tara.rezapour@gmail.com. The OSF project overview is available at https://osf.io/q6w9d/. Participant-level data are not publicly downloadable and will be provided only after review and approval of a reasonable request. How to obtain: Requests should be submitted by email to the corresponding author and should briefly describe the research purpose, planned analyses, investigators, and data-security procedures. The corresponding author and study team will review the request for scientific appropriateness, ethical acceptability, participant confidentiality, and feasibility. If approved, the requester may be asked to sign a data-use agreement before receiving the de-identified data and supporting materials. Applicants should generally allow approximately 2–4 weeks for review and response. Comments:
public Matin Toulami
No.7, Sheibani Alley, North Jamalzadeh St., West Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1418643514 +98 21 6642 6816 matin.toulami08@gmail.com Institute for Cognitive Science Studies scientific Tara Rezapour
Institute for Cognitive Science Studies, Cognitive Science Blvd.
Pardis Iran (Islamic Republic of) 1658344575 +98 21 7629 1130 tara_rezapour@yahoo.com Institute for Cognitive Science Studies Iran (Islamic Republic of) Iran (Islamic Republic of) History of Opioid Use Methadone Maintenance Treatment Receivers Ability to Read and Write 18 years 50 years Both Chronic Mental Disorder History F11 Opioid related disorders Behavior Behavior Participants in the CIREF group completed three 75-minute intervention sessions following baseline assessment and personalized cue development. Six individualized opioid-related cues were selected for future time intervals (1 day, 1 week, 1 month, 3 months, 6 months, and 1 year). In each session, cue exposure was followed by four stages of episodic future thinking: (1) simulation of a future cue-related event, (2) prediction and appraisal of possible responses and outcomes, (3) formation of a specific adaptive intention or goal, and (4) development of concrete action plans. Phasic craving (DDQ) was assessed before and after each session, while tonic craving (OCDUS) and delay discounting (MCQ) were assessed before and after the intervention period. Participants in the ERT active control group completed the same intervention dose, session structure, cue-exposure procedures, and therapist-guided exercises as the CIREF group. Six individualized opioid-related cues were linked to recent-past intervals (1, 2, 3, 5, 7, and 9 days earlier). Each cue was followed by episodic retrieval of a recent-past event, prediction and appraisal of responses and outcomes, intention formation, and planning. The main difference from CIREF was temporal orientation: past-oriented retrieval in ERT versus future-oriented simulation in CIREF. DDQ was assessed before and after each session, while OCDUS and MCQ were assessed before and after the intervention period. The primary outcome measure of the present study will be momentary craving assessed by the score of 3 sub-scales of the Desire for Drug Questionnaire. The sub-scales including: questions 1, 2, 4, 6, 7, 10, 13 investigate the patient’s “desire and intention to drug use”, questions 5, 9, 11, 12 investigate the “negative reinforcement for drug use" and questions 3 and 8 which are related to “drug abuse control”. There is no normal score for this questionnaire and the significance level of change is the evaluation criterion. Score received in each sub-scales will be assessed at baseline and after intervention. Timepoint: Before and after each intervention session. Method of measurement: 13-item Desire for Drug Questionnaire by Franken et al. will be used to assess the momentary craving. 14The primary outcome measure of the present study will be craving in the past period assessed by the score of 4 sub-scales of Obsessive Compulsive Drug Use Scale. The sub-scales including: questions 1, 2, 7, 8 investigate “desire and mental preoccupation with drugs”, questions 3 and 9 could be called as “the effect of desire for drug, and drug-related thoughts on the patient’s work and life”, questions 4, 6, 11 and 12 are related to “motivation, emotion, and lack of control” and questions 5 and 10 evaluate “resistance to drug use”. score for this questionnaire and the significance level of change is the evaluation criterion. Score received in each sub-scales will be assessed at baseline and after intervention. Timepoint: Baseline and after 4-week interventions. Method of measurement: 10-item Obsessive Compulsive Drug Use Scale by Franken et al. will be used to assess the craving in the past period. The secondary outcome of the present study is the score obtained in the dual monetary selection questionnaire. Timepoint: At baseline and after 4-weeks of intervention. Method of measurement: Delay Discounting will be assessed by Monetary Choice Questionnaire.Monetary Choice Questionnaires is a 27-item, brief dichotomous choice tasks that assess preference between small immediate and larger delayed monetary outcomes. Institute for Cognitive Science Studies Approved 2021-10-04 Research Ethics Committees of Institute for cognitive science studies Institute for Cognitive Science Studies, Cognitive Science Blvd, Pardis Pardis Tehran Iran (Islamic Republic of)