Opioid Use DisorderNCT06081985
Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
A study testing Transcranial Magnetic Stimulation with double-cone coil in people with Opioid Use Disorder, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Deep TMS to the left dorsolateral prefrontal cortex intervention to reduce craving and recurrent opioid use among patients with opioid use disorder who are abstinent for at least one week. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Transcranial Magnetic Stimulation with double-cone coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2021to 1 Apr 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18- 65
- Clinical diagnosis of opioid use disorder
Who cannot join
- Currently pregnant or breastfeeding
- Mental retardation, bipolar disorder, any psychotic disorder
- Neurological diseases such as epilepsy, ischemic stroke, multiple sclerosis
- History of head trauma that resulted in loss of consciousness for ≥5 minutes and retrograde amnesia for ≥30 minutes (self-reported history)
- Any history of seizures other than febrile childhood seizures (self-reported history)
- Clinically significant hearing impairment
- Having any prosthesis, such as an implant and pacemaker.
- Illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
Deep TMS to the left dorsolateral prefrontal cortex intervention to reduce craving and recurrent opioid use among patients with opioid use disorder who are abstinent for at least one week.
Read the detailed description
The participants will undergo baseline assessments, including rating scales and urine opioid metabolite tests. The participants will receive one of two treatments: High-frequency (10Hz, 3000 pulses per session) dTMS using a double cone coil targeting the left dorsolateral prefrontal cortex or sham stimulation. Each treatment will be preceded by a short-guided imagery (2-3 min) design to activate the relevant brain circuitry (provocation of symptoms may increase the response rate to deep TMS as was evident in the treatment of PTSD, cigarette smoking, and OCD). dTMS sessions will be conducted 10 times per week for 2 weeks, for 20 sessions. 8 weeks of patient follow-up, including clinical visits at weeks 0, 2, and 8. During this phase, subjective and objective measures of opioid use (self-report and analysis of urine samples for opioid metabolite) will be collected. Following the completion of the main part by the individual, an "open-label" treatment using the same parameters of the experiment will be offered (regardless of the treatment group).
- Conditions
- Opioid Use Disorder
- Being tested
- Transcranial Magnetic Stimulation with double-cone coil, Transcranial Magnetic Stimulation with sham coil
- Keywords
- Transcranial Magnetic Stimulation, Opioid Use Disorder
- 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.
Transcranial Magnetic Stimulation with double-cone coilDevice
Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil
Transcranial Magnetic Stimulation with sham coilDevice
Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil
| Study group | Role | What they receive |
|---|---|---|
| Active TMS | Active comparator | Deep TMS to the left dorsolateral prefrontal cortex with double-cone coil Receives: Device: Transcranial Magnetic Stimulation with double-cone coil |
| Sham TMS | Sham comparator | Sham TMS to the left dorsolateral prefrontal cortex with sham coil Receives: Device: Transcranial Magnetic Stimulation with sham coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
craving
craving severity for drug use- Visual Analog Scale (VAS). The minimum and maximum values are 0-10. Higher scores mean a worse outcome.
Measured: pretreatment, 2 weeks, and 8 weeks
Secondary outcomes (4)
Impulsivity severity
The Barratt Impulsiveness Scale-11 (BIS). The minimum and maximum scores are 30-120. Higher scores mean a worse outcome.
Measured: pretreatment, 2 weeks, and 8 weeks
Depression severity
The Hamilton Depression Rating Scale. The minimum and maximum scores are 0-52. Higher scores mean a worse outcome.
Measured: pretreatment, 2 weeks, and 8 weeks
Anxiety severity
Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome.
Measured: pretreatment, 2 weeks, and 8 weeks
Opioid use
opioid metabolite in urine.
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start21 Oct 2021
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Yücens, Pamukkale University
- Investigators
- Bengu Yucens, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081985
- Sponsor's protocol ID
- 2021TIPF026
- Status last verified
- Nov 2024
- First submitted
- 2 Oct 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guldas S, Tumkaya S, Yucens B. Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder: A Double-Blind, Placebo-Controlled Randomized Trial. Addict Biol. 2025 Jun;30(6):e70057. doi: 10.1111/adb.70057.
PubMed 40536869
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06081985
- Acronym / sponsor ID
- 2021TIPF026
- Conditions
- Opioid Use Disorder
- Keywords
- Transcranial Magnetic Stimulation, Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 13 Oct 2023 (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.
Deep TMS to the left dorsolateral prefrontal cortex intervention to reduce craving and recurrent opioid use among patients with opioid use disorder who are abstinent for at least one week.
Detailed description
The participants will undergo baseline assessments, including rating scales and urine opioid metabolite tests. The participants will receive one of two treatments: High-frequency (10Hz, 3000 pulses per session) dTMS using a double cone coil targeting the left dorsolateral prefrontal cortex or sham stimulation. Each treatment will be preceded by a short-guided imagery (2-3 min) design to activate the relevant brain circuitry (provocation of symptoms may increase the response rate to deep TMS as was evident in the treatment of PTSD, cigarette smoking, and OCD). dTMS sessions will be conducted 10 times per week for 2 weeks, for 20 sessions. 8 weeks of patient follow-up, including clinical visits at weeks 0, 2, and 8. During this phase, subjective and objective measures of opioid use (self-report and analysis of urine samples for opioid metabolite) will be collected. Following the completion of the main part by the individual, an "open-label" treatment using the same parameters of the experiment will be offered (regardless of the treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TMS | Active comparator | Device: Transcranial Magnetic Stimulation with double-cone coilDeep TMS to the left dorsolateral prefrontal cortex with double-cone coil |
| Sham TMS | Sham comparator | Device: Transcranial Magnetic Stimulation with sham coilSham TMS to the left dorsolateral prefrontal cortex with sham coil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18- 65
- Clinical diagnosis of opioid use disorder
Key exclusion criteria (8 listed)
- Currently pregnant or breastfeeding
- Mental retardation, bipolar disorder, any psychotic disorder
- Neurological diseases such as epilepsy, ischemic stroke, multiple sclerosis
- History of head trauma that resulted in loss of consciousness for ≥5 minutes and retrograde amnesia for ≥30 minutes (self-reported history)
- Any history of seizures other than febrile childhood seizures (self-reported history)
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 |
|---|---|---|
| Transcranial Magnetic Stimulation with double-cone coilDeep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil | Device | Active TMS |
| Transcranial Magnetic Stimulation with sham coilTranscranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil | Device | Sham TMS |
Primary outcome
craving
Time frame: pretreatment, 2 weeks, and 8 weeks
craving severity for drug use- Visual Analog Scale (VAS). The minimum and maximum values are 0-10. Higher scores mean a worse outcome.
4 secondary outcomes
Impulsivity severity
Time frame: pretreatment, 2 weeks, and 8 weeks
Depression severity
Time frame: pretreatment, 2 weeks, and 8 weeks
Anxiety severity
Time frame: pretreatment, 2 weeks, and 8 weeks
Opioid use
Time frame: 8 weeks of treatment
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 20 Nov 2024.
- Derived from this study: PubMed 40536869Guldas S, Tumkaya S, Yucens B. Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder: A Double-Blind, Placebo-Controlled Randomized Trial. Addict Biol. 2025 Jun;30(6):e70057. doi: 10.1111/adb.70057.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
Bengu Yucens study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation with double-cone coil in people with Opioid Use Disorder, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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 20 Nov 2024. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
craving (time frame: pretreatment, 2 weeks, and 8 weeks). 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 NCT06081985, which also lists 1 linked publication.
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 20 Nov 2024.