Protocol summary

Study aim
The current study aimed to investigate the efficacy of drug cue-exposure combined with episodic future thinking (CIREF) on craving and Delay Discounting in a sample of individuals with opioid use history receiving Methadone Maintenance Treatment (MMT).
Design
A randomized, double blinded clinical trial with a two arm parallel group designed of 28 Participants. Applying Python for the randomization.
Settings and conduct
This study will be performed in 4 one-hour sessions for four weeks with 28 subjects in one of the outpatient clinics for addiction treatment. After Initial and second screening, eligible individuals will be randomly allocated to trial and control groups. In the first session, momentary craving, craving in the past and delay discounting will be measured. Then, Individuals will be asked to generate opioid-related cues for 6 time intervals and rate each of them. (trial: 1 week, 1, 3, 6 months, and 1 year in future Control: 9,7,5 , Last 3, 1 and 11 days in the past). Cues which will receive normal score in arousal, valence, and vividness will be applied in the intervention. In second sessions, the cues will be presented again and 4 stages of EFT including simulation, prediction, Intention and Plan will be executed. At the end, the amount of craving and the value of procrastination will be measured again.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Individuals with a history of opioid use currently receiving Methadone maintenance treatment ≤ 150 mg Acquire normal score on the Beck Depression Inventory, Snaith-Hamilton Pleasure Scale and Montreal Cognitive Assessment in the initial Screening Ability to generate the opioid-related cues in the second screening Exclusion Criteria: Not having the mentioned criteria above
Intervention groups
Episodic Future Thinking
Main outcome variables
Momentary Craving Craving in the past time frame Delay Discounting

General information

Reason for update
Acronym
CIREF
IRCT registration information
IRCT registration number: IRCT20210804052079N1
Registration date: 2022-06-02, 1401/03/12
Registration timing: prospective

Last update: 2022-06-02, 1401/03/12
Update count: 0
Registration date
2022-06-02, 1401/03/12
Registrant information
Name
Matin Toulami
Name of organization / entity
Institute for Cognitive Science Studies
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 6816
Email address
matin.toulami08@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-06, 1401/03/16
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cue-Exposure Combined with Episodic Future Thinking (CIREF) Intervention on Craving and Delay Discounting in Opioid Users Receiving Methadone Maintenance Treatment: A Pilot Study
Public title
The Effect of Episodic Future Thinking (EFT) on Craving
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
History of Opioid Use Methadone Maintenance Treatment Receivers Ability to Read and Write
Exclusion criteria:
Chronic Mental Disorder History
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
After screening, participants meeting the required inclusion criteria will be randomly allocated to the intervention and the active control group through block randomization. The randomization list will be created using Python. In block randomization, there would be only six conditions in which two cells get “C” control and two cells get “T” trial for a block of four cells. As a result, the 6 outcomes will be as follows: 1: CCTT, 2: TTCC, 3: CTCT, 4: TCTC, 5: TCCT, 6: CTTC. Also, a number will be randomly assigned to each participant.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, after screening and randomization, individuals will be officially included in the study. In the first session of the intervention, a brief description of the study process by the examiner will be provided to the participant. They will then be given an informed consent form. The information contained in the informed consent form and how to spend the study will be fully explained to the participants. In the process of conducting the study, participants will be blind to the intervention received. It should be noted that the staff present at the outpatient clinic will be blind to the whole intervention process. These people are: nurse, psychologist, assistant and also the technical manager of the clinic. All data recorded during the intervention sessions will be stored in the computer of the outpatient clinic (the venue of the intervention sessions) in an encrypted folder that only the researcher has access to, and will be deleted after the intervention and follow-up sessions. At the end of the intervention sessions, only the data obtained from the questionnaires will be provided to the data analyzer.
Placebo
Not used
Assignment
Parallel
Other design features
In the present study, an intervention called " Intervention based on Episodic Future Thinking (EFT)" has been designed for the first time. It consists of 4 one-hour sessions. The protocol tries to be feasible and led participants to remain in the study. The set of opioid narrative cues, applied in the intervention have been completely personalized.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Institute for cognitive science studies
Street address
Institute for Cognitive Science Studies, Cognitive Science Blvd, Pardis
City
Pardis
Province
Tehran
Postal code
۱۶۵۸۳۴۴۵۷۵
Approval date
2021-10-04, 1400/07/12
Ethics committee reference number
IR.UT.IRICSS.REC.1400.011

Health conditions studied

1

Description of health condition studied
Opioid Substance Use
ICD-10 code
F11
ICD-10 code description
Opioid related disorders

Primary outcomes

1

Description
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, 14 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
Baseline and after 4-week interventions
Method of measurement
14-item Desire for Drug Questionnaire by Franken et al. will be used to assess the momentary craving.

2

Description
The 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.

Secondary outcomes

1

Description
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.

Intervention groups

1

Description
Trial group: Episodic Future thinking group: In the first session, the subjects of the intervention group will be asked to generate the opioid-related cues for the the following for the next 6 time intervals, including: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year in future. Subjects will then scored them in terms of Valence, arousal, and vividness.Momentary craving, craving in the past period and the delay discounting will be measured. Next, the subject will be shown the cues of the relevant time intervals on the screen. In the first stage of the Episodic Future thinking, the subject will be asked to simulate a possible future event in his/her mind based on the related cue. In the second stage, he will be asked to predict all the details of the event in 2-3 minutes. The drug-related cues will trigger the drug-related memories which cause in negative retrieval. In the third stage, the subject's memory will be fragile and vulnerable due to stimulation. Now the person will be asked to think about the consequences of substance abuse and form a new interpretation and pursue this interpretation as a goal in his mind. This goal is actually a kind of new memory that is created in a person's mind called reappraisal. In the fourth step, the subject will be asked to plan small but strong steps to achieve the leading plan. These small steps will help him to have a predetermined plan to achieve his goal and also be able to manage his craving toward drug cues. After the intervention sessions, momentary craving, craving in the past period and delay discounting will be measured again.
Category
Behavior

2

Description
Control group: Control group: Episodic Recent thinking group: In the first session, the subjects of the intervention group will be asked to generate the opioid-related cues for the the following for the next 6 time intervals, including: 1,3,5,7,9 days in the past. Subjects will then scored them in terms of Valence, arousal, and vividness.Momentary craving, craving in the past period and the delay discounting will be measured. Next, the subject will be shown the cues of the relevant time intervals on the screen. In the first stage of the Episodic Recent thinking, the subject will be asked to simulate a possible event in the recent past based on the related cue. In the second stage, he will be asked to predict all the details of the event in 2-3 minutes. Now the person will be asked to set a new goal toward the drug-related cue. In the fourth step, the subject will be asked to plan small steps to achieve the leading goal. After the intervention sessions, momentary craving, craving in the past period and delay discounting will be measured again.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Marjan Outpatient Methadone Maintenance Treatment Clinic
Full name of responsible person
Keyvan Ghasemi
Street address
Shahid Motahari St. Ghomi Alley
City
Pakdasht
Province
Tehran
Postal code
3391657963
Phone
+98 21 3603 9800
Email
Keyvan.ghasemi.901@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cognitive Sciences and Technologies Council
Full name of responsible person
Kamal Kharazi
Street address
No 35, CSTC Building, Alvand St, Argentina Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1967875319
Phone
+98 21 2266 0770
Fax
Email
research.project@cogc.ir
Web page address
https://cogc.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cognitive Sciences and Technologies Council
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Matin Toulami
Position
Master Degree Student
Latest degree
Bachelor
Other areas of specialty/work
Cognitive Neuroscience
Street address
No.7, Sheibani Alley, North Jamalzadeh St., West Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1418643514
Phone
+98 21 6642 6816
Email
matin.toulami08@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Tara Rezapour
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Institute for Cognitive Science Studies, Cognitive Science Blvd.
City
Pardis
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Fax
+98 21 7629 1140
Email
tara_rezapour@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Institute for Cognitive Science Studies (ICSS)
Full name of responsible person
Matin Toulami
Position
Master Degree Student
Latest degree
Bachelor
Other areas of specialty/work
Cognitive Neuroscience
Street address
No7, Sheibani Alley, No. Jamalzadeh St., West Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1418643514
Phone
+98 21 6642 6816
Email
matin.toulami08@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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