Addiction OpiateNCT05256485
Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving
A study testing cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy in people with Addiction Opiate, run by Sara Harby at 1 site in Egypt.
Trial summary
the study aim is to compare betwenn the effect of mindfulness based relapse prevention and other evidence based psychotherapy interventions regaring substance craving. Read more about this study
- Who is it for?
- Ages 15 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Addiction Opiate
- What is being tested?
- cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2019to 10 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 50 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 15-50 years.
- Male gender.
- Patients meet DSM-5(3) criteria of opioid abuse.
- Had completed detoxification in a treatment center.
- Willing to give consent they will be randomly assigned to either CBT, MBRP, or twelve-step treatment group.
- Patients have dual diagnoses.
- Patients have poly-substance use disorder.
Who cannot join
- Participants with significant cognitive disorder.
- Participants with suicidal thoughts.
- Participants with any organic condition affecting stress response and so craving such as hypertension, respiratory or cardiovascular disorders.
- Participants taking any medications (e.g., antipsychotics in high doses) known to affect the stress response.
- Participants relapsed to drug abuse during therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effect of Cognitive Behavioral Therapy, Mindfulness Based Relapse Prevention and Twelve-step Therapy in Patients With Opioid Craving
the study aim is to compare betwenn the effect of mindfulness based relapse prevention and other evidence based psychotherapy interventions regaring substance craving.
Read the detailed description
In this prospective study, the population included opioid-dependent men (aged 18-50 years), some of them were admitted to El Maamora hospital and others were attendees in NA. To conduct this research, considering the drop-out rate, the list of 60 persons applying for treatment was prepared based on inclusion and exclusion criteria.
Then, three groups of 20 were randomly selected and placed in three intervention groups, group one received CBT, group two received MBRP, and group three received twelve-step therapy.
The subjects were assigned randomly to the treatment condition via a computer-generated random number with the aid of trained staff at the clinic blindly.
All participants completed the measurement scales immediately after detoxification (pre-test) and after the end of therapeutic sessions (post-test).
- Conditions
- Addiction Opiate
- Being tested
- cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapyBehavioural
In cognitive-behavioral therapy, participants learned that thoughts and emotions contribute to behavior, and responses to thoughts and emotions can be controlled.
in mindfulness-based relapse prevention, participants learned to focus on the present moment experience including craving with an attitude of acceptance and non-judging.
In twelve-step therapy, participants learned principles of acceptance, gratitude, forgiveness, tolerance, patience, humility, and honesty together with participation in different healthy ways to enrich life.
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavioral therapy | Active comparator | Standard CBT comprises an array of approaches directed toward modifying dysfunctional thinking and behavior. The two critical components are analysis of thoughts, feelings, and behaviors, as well as skills training for achieving active behavior and thought modification. Receives: Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy |
| mindfulness based relapse prevention | Active comparator | MBRP training is based on a two-component process:
1. Attention to present moment experience, even if it includes craving or negative emotion.
2. An accepting attitude towards this experience letting it be exactly as it is, without judging it or reacting to it. Receives: Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy |
| twelve-step therapy | Active comparator | 12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation Receives: Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid craving scale
A visual analog scale, a modification of the Cocaine Craving Scale, is a 3-item scale used to measure the opioid craving and each item is ranging from 0 to 10 (0 means no craving at all and 10 means severe craving).
Measured: 5 minutes
Secondary outcomes (2)
The Obsessive-Compulsive Drug use Scale
it measures craving in the previous ten days and includes 13 questions. Subjects should select from 5 graded options for each question based on their experiences during last week. The items were rated as follow:1) Never; 2) Rarely; 3) Sometimes; 4) Mostly and 5) Always
Measured: 15 minutes
The desire for a drug questionnaire
it measures instant (now) craving, includes 14 questions and participants answer questions on a seven-step Likert-scale answer sheet based on what he/she feels or thinks at the moment. The items were rated as follows: 1) not at all; 2) mild; 3) mild to moderate; 4) moderate; 5) moderate to severe; 6) severe and 7) approximately complete
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start15 Oct 2019
- Primary completion30 Jun 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addiction OpiateStudies 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
- Model description
- Standard cognitive behavioral therapy comprises approaches directed toward modifying dysfunctional thinking and behavior discussed through 8 sessions. mindfulness based relapse prevention is an 8-week therapy program based on: 1. Attention to present moment experience, even if it includes craving or negative emotion. 2. An accepting attitude towards this experience letting it be exactly as it is, without judging it or reacting to it. This group therapy was facilitated by an ex-addict working in El Maamora hospital. 12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Harby
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Harby, Alexandria University
- Investigators
- Tarek K Molokhia, Phd, Study chair, professor of neuropsychiatryOsama A Elkholy, Phd, Study chair, professor of neuropsychiatryAhmed M Abdelkreem, Phd, Study director, lecturer of neuropsychiatrySara A Harby, master, Principal investigator, assistant lecturer of psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256485
- Sponsor's protocol ID
- RPC£0521190906
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Cognitive Behavioral Therapy, Mindfulness Based Relapse Prevention and Twelve-step Therapy in Patients With Opioid Craving
- ClinicalTrials.gov ID
- NCT05256485
- Acronym / sponsor ID
- RPC£0521190906
- Conditions
- Addiction Opiate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sara HarbyUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study aim is to compare betwenn the effect of mindfulness based relapse prevention and other evidence based psychotherapy interventions regaring substance craving.
Detailed description
In this prospective study, the population included opioid-dependent men (aged 18-50 years), some of them were admitted to El Maamora hospital and others were attendees in NA. To conduct this research, considering the drop-out rate, the list of 60 persons applying for treatment was prepared based on inclusion and exclusion criteria.
Then, three groups of 20 were randomly selected and placed in three intervention groups, group one received CBT, group two received MBRP, and group three received twelve-step therapy.
The subjects were assigned randomly to the treatment condition via a computer-generated random number with the aid of trained staff at the clinic blindly.
All participants completed the measurement scales immediately after detoxification (pre-test) and after the end of therapeutic sessions (post-test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Standard cognitive behavioral therapy comprises approaches directed toward modifying dysfunctional thinking and behavior discussed through 8 sessions. mindfulness based relapse prevention is an 8-week therapy program based on: 1. Attention to present moment experience, even if it includes craving or negative emotion. 2. An accepting attitude towards this experience letting it be exactly as it is, without judging it or reacting to it. This group therapy was facilitated by an ex-addict working in El Maamora hospital. 12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation.
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioral therapy | Active comparator | Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapyStandard CBT comprises an array of approaches directed toward modifying dysfunctional thinking and behavior. The two critical components are analysis of thoughts, feelings, and behaviors, as well as skills training for achieving active behavior and thought modification. |
| mindfulness based relapse prevention | Active comparator | Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapyMBRP training is based on a two-component process: 1. Attention to present moment experience, even if it includes craving or negative emotion. 2. An accepting attitude towards this experience letting it be exactly as it is, without judging it or reacting to it. |
| twelve-step therapy | Active comparator | Behavioral: cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age: 15-50 years.
- Male gender.
- Patients meet DSM-5(3) criteria of opioid abuse.
- Had completed detoxification in a treatment center.
- Willing to give consent they will be randomly assigned to either CBT, MBRP, or twelve-step treatment group.
Key exclusion criteria (5 listed)
- Participants with significant cognitive disorder.
- Participants with suicidal thoughts.
- Participants with any organic condition affecting stress response and so craving such as hypertension, respiratory or cardiovascular disorders.
- Participants taking any medications (e.g., antipsychotics in high doses) known to affect the stress response.
- Participants relapsed to drug abuse during therapy.
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 |
|---|---|---|
| cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapyIn cognitive-behavioral therapy, participants learned that thoughts and emotions contribute to behavior, and responses to thoughts and emotions can be controlled. in mindfulness-based relapse prevention, participants learned to focus on the present moment experience including craving with an attitude of acceptance and non-judging. In twelve-step therapy, participants learned principles of acceptance, gratitude, forgiveness, tolerance, patience, humility, and honesty together with participation in different healthy ways to enrich life. | Behavioural | cognitive behavioral therapy, mindfulness based relapse prevention, twelve-step therapy |
Primary outcome
opioid craving scale
Time frame: 5 minutes
A visual analog scale, a modification of the Cocaine Craving Scale, is a 3-item scale used to measure the opioid craving and each item is ranging from 0 to 10 (0 means no craving at all and 10 means severe craving).
2 secondary outcomes
The Obsessive-Compulsive Drug use Scale
Time frame: 15 minutes
The desire for a drug questionnaire
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Addiction Opiate
Active, not recruiting
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MethaLoad Dose-Finding Study
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Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
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Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
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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.
Tarek K Molokhia, Phd study chair
professor of neuropsychiatry
Osama A Elkholy, Phd study chair
professor of neuropsychiatry
Ahmed M Abdelkreem, Phd study director
lecturer of neuropsychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy in people with Addiction Opiate, run by Sara Harby at 1 site in Egypt.
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 7 inclusion and 5 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 25 Feb 2022. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
opioid craving scale (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2022.