Opioid Use DisorderNCT05635682
Investigation of the Relationship Between Different Assesments in Individuals in Opioid Maintenance Treatment Process
An observational study of Opioid Use Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Opioid use disorder is the chronic use of opioids that causes clinically significant distress or impairment. More than 16 million people world wide are opioid addicts. The diagnosis of opioid use disorder is based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Observational and anthropometric assesments
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 15 Apr 2023
- Phase
- Observational
- 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
- Men only
- Adult, Older adult
Study population: This study will be conducted with the participation of 138 individuals, 40 individuals and 40 healthy individuals, between the ages of 18-65, who voluntarily agreed to participate in the study, who had an opioid use disorder according to DSM V diagnostic criteria and who were in the process of maintenance treatment.
Who may be able to join
- To be male and between the ages of 18-65,
- For the study group, diagnosed with opioid use disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders V (DSM V) and being on maintenance treatment,
- To voluntarily agree to participate in the study,
Who cannot join
- Having any systemic or neurological disease,
- To have a cognitive effect at a level that will affect communication,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Sensation, Balance, Gait, Posture and Reaction Time in Individuals in Opioid Maintenance Treatment Process
Opioid use disorder is the chronic use of opioids that causes clinically significant distress or impairment. More than 16 million people world wide are opioid addicts. The diagnosis of opioid use disorder is based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Despite the social and personal consequences of opioid use disorder in individuals; It consists of an excessive desire to use opioids, increased opioid tolerance, and withdrawal syndrome when discontinued. Examples of opioids include heroin, morphine, codeine, synthetic opioids such as fentanyl and oxycodone.
In many countries, the main pharmacological approach in the treatment of opioid use disorder is maintenance therapy using opioid agonists. The combination of buprenorphine and naloxone is one of the most effective agents used in maintenance therapy. Due to the effects of both opioid use and maintenance therapy, these individuals have sensory problems, balance and gait disturbances, and a prolonged reaction time.
The aim of this study is to examine the relationship between sensation, balance, gait, posture and reaction time in individuals on opioid maintenance therapy and to compare them with healthy individuals.
Read the detailed description
This study will be conducted with the participation of 80 people between the ages of 18 and 65, including 40 individuals who have voluntarily agreed to participate in the study, who have received opioid use disorder according to the DSM V diagnostic criteria and are in the process of maintenance treatment, and 40 healthy individuals. Dec.
Within the scope of the study, the cognitive levels of the participants will be evaluated by Montreal Cognitive Assessment (MoCA).
Sensory evaluations will be made in the form of proprioception sense, light touch sense, vibration sense and two-point discrimination assessment. Proprioception assessments will be performed using a digital inclinometer for the neck and torso separately (J-Tech Dualer IQ, J-Tech Medical Industries, Salt Lake City, USA).
The posture assessment will be performed by the New York Posture Analysis Method.
The Semmes Weinstein Monofilament Test (SWMT) will be used to assess the sense of touch and pressure on the sole of the foot.The test will be applied to the first metatarsal head, medial foot, lateral foot and heel. 3 Repetitions will be performed for each zone. At the end of the test, the values of the four regions will be added and divided into four and the average value will be calculated. The right and left extremities will be evaluated separately.
A 128 Hz diaposon will be used to assess the sense of vibration. The test will be applied to the first metatarsal head, medial foot, lateral foot and heel. The right and left extremities will be evaluated separately.
Discriminator (Baseline ® Discrimin-A-Gon 2) for the assessment of the sense of two-point separation- Point Discriminator, New York, USA) will be used. The test will be applied to the first metatarsal head, medial foot, lateral foot and heel.The right and left extremities will be evaluated separately.
For balance and walking; Tinetti Balance and Walking Test will be applied. Reaction time will be assessed by the Nelson foot test. By taking five measurements, the best and worst values will be discarded, and the average of the remaining three measurements will be recorded as the distance at which the ruler fell.
- Conditions
- Opioid Use Disorder
- Being tested
- Observational and anthropometric assesments
- Keywords
- opioid use disorder, plantar sensation, reaction time, balance, gait
- 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.
Observational and anthropometric assesmentsOther
Plantar sensation, foot reaction time, head and trunk proprioceptions, posture, balance and gait assesments
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Individuals in the process of maintenance therapy with opioid use disorder Receives: Other: Observational and anthropometric assesments | |
| Control Group | Healty people Receives: Other: Observational and anthropometric assesments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar sensation -Tactile sense-
Tactile sense was assessed using a full Semmes-Weinstein Monofilament test kit (North Coast Medical, San Jose, CA, USA). The smallest (1.65) monofilament was used firstly. The trial test was performed once before the assessment with eyes open and closed to introduce the test to each child. The monofilament was held perpendicular to the skin and pressed into the skin until it was slightly dished and held for 1.5 s in the pressed region and 1.5 s in the air. The child was asked to indicate if he/she felt the touch.
Measured: 1. Day
Plantar sensation - Vibration sense-
A 128 Hz tuning fork (Baseline® Tuning Fork, New York, USA) was used to assess the vibration sense. The duration of the vibration was measured by a chronometer, started when the fork touched to the child's skin and stopped when the child indicated that "it has finished".
Measured: 1. Day
Plantar sensation - Two-point discrimination sense-
A discriminator (Baseline®Discrim-A-Gon 2-Point Discriminator, New York, USA) was used for the assessment of the two-point discrimination sense. The assessment was started at the maximum distance and gradually decreased until the child was not able to differentiate the two points. When the subject felt the two points as one in two of the three trials, the distance was noted in mm. Light pressure was applied simultaneously at both ends of the discriminator to apply as equal pressure as possible.
Measured: 1. Day
Reaction time - Foot reaction time-
Reaction time was evaluated with Nelson's foot test. For the test, the subject sits against the wall with the toe tip 2.5 cm and the heel part 5 cm. The test administrator will hold the reaction ruler between the wall and the subject's foot, and when the subject is ready, he will release the ruler and the subject holds the fallen ruler by squeezing it against the wall with his foot. Five measurements were taken and the best and worst values were discarded, and the average of the remaining three measurements was recorded as the distance the ruler fell.
Measured: 1. Day
Proprioception-Neck proprioception
For neck prorioception; One end of the dual digital inclinometer is placed at the level of the 7th cervical vertebra and the other end is placed on the apex of the participant's head. The person is asked to close their eyes. After the neck is brought to the reference angle, it is ensured that the person perceives the angle by waiting for 10 seconds. Then, the person is asked to bring his head to an upright position and then repeat the taught reference angle as he perceives it. The absolute value of the angle at which it deviates from the target is recorded. In our study, 30° neck flexion will be accepted as the target angle value and the average of the evaluations was taken by making 3 evaluations.
Measured: 1. Day
Proprioception-Trunk proprioception
For trunk proprioception, in the standing position, the first part of the inclinometer is fixed on the S1 spinous process, which is located and marked by palpation, and the second part is fixed on the T1 spinous process, which is also determined and marked by palpation, and the eyes of the person are closed. After the body is brought to the reference angle, it is ensured that the person perceives the angle by waiting for 10 seconds. Then, the person is asked to bring his/her torso to an upright position and then repeat the taught reference angle as he/she perceives it. The absolute value of the angle at which it deviates from the target is recorded. In our study, 30° trunk flexion will be accepted as the target angle value, and 3 evaluations were made and the average of the evaluations was taken.
Measured: 1. Day
Posture
Posture assessment was done with the New York Posture Analysis (NYPA). The NYPA is a quantitative scale that evaluates whether the alignment of various body segments is appropriate for an individual in an anatomical position. NYPA has a form in which the body is examined in thirteen separate sections, and the posture assessment is scored using the visuals in these sections.
Measured: 1. Day
Balance and Gait-Tinetti Balance And Gait Test
For balance and walking; Tinetti Balance and Gait Test was applied. The balance test includes sitting balance, standing and standing balance, evaluation of balance with eyes open and closed, 360 degree rotation around itself and evaluation of reaching. In the walking test, initiation of walking, step height, step width, step symmetry, step continuity, deviation from the walking line and trunk stability are evaluated. The questions are scored between 0-2, with a maximum of 26 points for balance and a maximum of 9 points for walking, with a total maximum score of 35. A total score of 18 or less indicates a high risk of falling, a score of 19-24 indicates a moderate fall risk, and a score of 24 and above indicates a low risk of falling.
Measured: 1. Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start15 Aug 2022
- Primary completion25 Feb 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Keser, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635682
- Sponsor's protocol ID
- 66442466-604.01.02
- Status last verified
- May 2026
- First submitted
- 27 Oct 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Sensation, Balance, Gait, Posture and Reaction Time in Individuals in Opioid Maintenance Treatment Process
- ClinicalTrials.gov ID
- NCT05635682
- Acronym / sponsor ID
- 66442466-604.01.02
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder, plantar sensation, reaction time, balance, gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 2 Dec 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.
Opioid use disorder is the chronic use of opioids that causes clinically significant distress or impairment. More than 16 million people world wide are opioid addicts. The diagnosis of opioid use disorder is based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Despite the social and personal consequences of opioid use disorder in individuals; It consists of an excessive desire to use opioids, increased opioid tolerance, and withdrawal syndrome when discontinued. Examples of opioids include heroin, morphine, codeine, synthetic opioids such as fentanyl and oxycodone.
In many countries, the main pharmacological approach in the treatment of opioid use disorder is maintenance therapy using opioid agonists. The combination of buprenorphine and naloxone is one of the most effective agents used in maintenance therapy. Due to the effects of both opioid use and maintenance therapy, these individuals have sensory problems, balance and gait disturbances, and a prolonged reaction time.
The aim of this study is to examine the relationship between sensation, balance, gait, posture and reaction time in individuals on opioid maintenance therapy and to compare them with healthy individuals.
Detailed description
This study will be conducted with the participation of 80 people between the ages of 18 and 65, including 40 individuals who have voluntarily agreed to participate in the study, who have received opioid use disorder according to the DSM V diagnostic criteria and are in the process of maintenance treatment, and 40 healthy individuals. Dec.
Within the scope of the study, the cognitive levels of the participants will be evaluated by Montreal Cognitive Assessment (MoCA).
Sensory evaluations will be made in the form of proprioception sense, light touch sense, vibration sense and two-point discrimination assessment. Proprioception assessments will be performed using a digital inclinometer for the neck and torso separately (J-Tech Dualer IQ, J-Tech Medical Industries, Salt Lake City, USA).
The posture assessment will be performed by the New York Posture Analysis Method.
The Semmes Weinstein Monofilament Test (SWMT) will be used to assess the sense of touch and pressure on the sole of the foot.The test will be applied to the first metatarsal head, medial foot, lateral foot and heel. 3 Repetitions will be performed for each zone. At the end of the test, the values of the four regions will be added and divided into four and the average value will be calculated. The right and left extremities will be evaluated separately.
A 128 Hz diaposon will be used to assess the sense of vibration. The test will be applied to the first metatarsal head, medial foot, lateral foot and heel. The right and left extremities will be evaluated separately.
Discriminator (Baseline ® Discrimin-A-Gon 2) for the assessment of the sense of two-point separation- Point Discriminator, New York, USA) will be used. The test will be applied to the first metatarsal head, medial foot, lateral foot and heel.The right and left extremities will be evaluated separately.
For balance and walking; Tinetti Balance and Walking Test will be applied. Reaction time will be assessed by the Nelson foot test. By taking five measurements, the best and worst values will be discarded, and the average of the remaining three measurements will be recorded as the distance at which the ruler fell.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Observational and anthropometric assesmentsIndividuals in the process of maintenance therapy with opioid use disorder |
| Control Group | – | Other: Observational and anthropometric assesmentsHealty people |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted with the participation of 138 individuals, 40 individuals and 40 healthy individuals, between the ages of 18-65, who voluntarily agreed to participate in the study, who had an opioid use disorder according to DSM V diagnostic criteria and who were in the process of maintenance treatment.
Key inclusion criteria (3 listed)
- To be male and between the ages of 18-65,
- For the study group, diagnosed with opioid use disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders V (DSM V) and being on maintenance treatment,
- To voluntarily agree to participate in the study,
Key exclusion criteria (2 listed)
- Having any systemic or neurological disease,
- To have a cognitive effect at a level that will affect communication,
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 |
|---|---|---|
| Observational and anthropometric assesmentsPlantar sensation, foot reaction time, head and trunk proprioceptions, posture, balance and gait assesments | Other | Control Group, Study Group |
Primary outcome
Plantar sensation -Tactile sense-
Time frame: 1. Day
Tactile sense was assessed using a full Semmes-Weinstein Monofilament test kit (North Coast Medical, San Jose, CA, USA). The smallest (1.65) monofilament was used firstly. The trial test was performed once before the assessment with eyes open and closed to introduce the test to each child. The monofilament was held perpendicular to the skin and pressed into the skin until it was slightly dished and held for 1.5 s in the pressed region and 1.5 s in the air. The child was asked to indicate if he/she felt the touch.
Plantar sensation - Vibration sense-
Time frame: 1. Day
A 128 Hz tuning fork (Baseline® Tuning Fork, New York, USA) was used to assess the vibration sense. The duration of the vibration was measured by a chronometer, started when the fork touched to the child's skin and stopped when the child indicated that "it has finished".
Plantar sensation - Two-point discrimination sense-
Time frame: 1. Day
A discriminator (Baseline®Discrim-A-Gon 2-Point Discriminator, New York, USA) was used for the assessment of the two-point discrimination sense. The assessment was started at the maximum distance and gradually decreased until the child was not able to differentiate the two points. When the subject felt the two points as one in two of the three trials, the distance was noted in mm. Light pressure was applied simultaneously at both ends of the discriminator to apply as equal pressure as possible.
Reaction time - Foot reaction time-
Time frame: 1. Day
Reaction time was evaluated with Nelson's foot test. For the test, the subject sits against the wall with the toe tip 2.5 cm and the heel part 5 cm. The test administrator will hold the reaction ruler between the wall and the subject's foot, and when the subject is ready, he will release the ruler and the subject holds the fallen ruler by squeezing it against the wall with his foot. Five measurements were taken and the best and worst values were discarded, and the average of the remaining three measurements was recorded as the distance the ruler fell.
Proprioception-Neck proprioception
Time frame: 1. Day
For neck prorioception; One end of the dual digital inclinometer is placed at the level of the 7th cervical vertebra and the other end is placed on the apex of the participant's head. The person is asked to close their eyes. After the neck is brought to the reference angle, it is ensured that the person perceives the angle by waiting for 10 seconds. Then, the person is asked to bring his head to an upright position and then repeat the taught reference angle as he perceives it. The absolute value of the angle at which it deviates from the target is recorded. In our study, 30° neck flexion will be accepted as the target angle value and the average of the evaluations was taken by making 3 evaluations.
Proprioception-Trunk proprioception
Time frame: 1. Day
For trunk proprioception, in the standing position, the first part of the inclinometer is fixed on the S1 spinous process, which is located and marked by palpation, and the second part is fixed on the T1 spinous process, which is also determined and marked by palpation, and the eyes of the person are closed. After the body is brought to the reference angle, it is ensured that the person perceives the angle by waiting for 10 seconds. Then, the person is asked to bring his/her torso to an upright position and then repeat the taught reference angle as he/she perceives it. The absolute value of the angle at which it deviates from the target is recorded. In our study, 30° trunk flexion will be accepted as the target angle value, and 3 evaluations were made and the average of the evaluations was taken.
Posture
Time frame: 1. Day
Posture assessment was done with the New York Posture Analysis (NYPA). The NYPA is a quantitative scale that evaluates whether the alignment of various body segments is appropriate for an individual in an anatomical position. NYPA has a form in which the body is examined in thirteen separate sections, and the posture assessment is scored using the visuals in these sections.
Balance and Gait-Tinetti Balance And Gait Test
Time frame: 1. Day
For balance and walking; Tinetti Balance and Gait Test was applied. The balance test includes sitting balance, standing and standing balance, evaluation of balance with eyes open and closed, 360 degree rotation around itself and evaluation of reaching. In the walking test, initiation of walking, step height, step width, step symmetry, step continuity, deviation from the walking line and trunk stability are evaluated. The questions are scored between 0-2, with a maximum of 26 points for balance and a maximum of 9 points for walking, with a total maximum score of 35. A total score of 18 or less indicates a high risk of falling, a score of 19-24 indicates a moderate fall risk, and a score of 24 and above indicates a low risk of falling.
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 14 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by Gazi 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 3 inclusion and 2 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 14 May 2026. 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. 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?
Plantar sensation -Tactile sense- (time frame: 1. Day). The study lists 8 primary outcomes in all. 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 14 May 2026.