Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06081985
Other study ID # 2021TIPF026
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 21, 2021
Est. completion date April 2024

Study information

Verified date October 2023
Source Pamukkale University
Contact Bengu Yucens, M.D.
Phone +905052633138
Email dr.bengubaz@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age 18- 65 - Clinical diagnosis of opioid use disorder Exclusion Criteria: - 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

Study Design


Intervention

Device:
Transcranial Magnetic Stimulation with double-cone coil
Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil
Transcranial Magnetic Stimulation with sham coil
Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil

Locations

Country Name City State
Turkey Bengu Yucens Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary craving craving severity for drug use- Visual Analog Scale (VAS). The minimum and maximum values are 0-10. Higher scores mean a worse outcome. pretreatment, 2 weeks, and 8 weeks
Secondary Impulsivity severity The Barratt Impulsiveness Scale-11 (BIS). The minimum and maximum scores are 30-120. Higher scores mean a worse outcome. pretreatment, 2 weeks, and 8 weeks
Secondary Depression severity The Hamilton Depression Rating Scale. The minimum and maximum scores are 0-52. Higher scores mean a worse outcome. pretreatment, 2 weeks, and 8 weeks
Secondary Anxiety severity Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome. pretreatment, 2 weeks, and 8 weeks
Secondary Opioid use opioid metabolite in urine. 8 weeks of treatment
See also
  Status Clinical Trial Phase
Recruiting NCT06021431 - Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT N/A
Completed NCT06266572 - Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment Phase 1
Recruiting NCT05037682 - Pain and Opioid Management in Older Adults N/A
Completed NCT06200740 - Remotely Observed Methadone Evaluation N/A
Not yet recruiting NCT06441604 - Extended-release Buprenorphine as a Novel Low-dose Induction Strategy Phase 2
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Completed NCT02593474 - Medication-Assisted Treatment for Youth With Substance Use Disorders Phase 1
Completed NCT02440256 - Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial N/A
Completed NCT02559973 - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder Phase 1
Completed NCT05587998 - A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users. Phase 1
Terminated NCT04577144 - An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
Recruiting NCT06001437 - Following Outcomes Remotely Within Addiction Recovery Domains
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2
Completed NCT05546229 - Assessment of Methadone and Buprenorphine in Interstitial Fluid
Not yet recruiting NCT06416020 - Integrating MOUD in African American Community Settings (Better Together) N/A
Not yet recruiting NCT06104280 - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment N/A
Recruiting NCT06206291 - Cannabidiol for Opioid Addiction Phase 2
Completed NCT05552040 - START NOW in the Treatment of Opioid Addicted Individuals N/A
Recruiting NCT05459922 - Adjunctive Bright Light Therapy for Opioid Use Disorder N/A
Recruiting NCT05343169 - Community-based Education, Navigation, and Support Intervention for Military Veterans N/A