Transcranial Photobiomodulation for the Treatment of Opioid Cravings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-11-15

Brief Summary

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The investigators wish to test the hypothesis that transcranial photobiomodulation (tPBM) (i.e., 4-minutes of 810nm near-infrared light at 250 mW/cm2 by LED to the forehead at F3 or F4 versus an indistinguishable placebo treatment) can safely reduce opioid craving in individuals with opioid dependence in a within-patient study.

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Detailed Description

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Opioid use disorders (OUD) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. The investigators have developed a novel treatment that combines transcranial photobiomodulation (t-PBM) and Schiffer's Dual Brain Psychology (DBP)

The investigators will use a randomized, double-blind, placebo-controlled protocol in which 22 patients with significant opioid cravings and a history of recent or current OUD attended three one-hour weekly sessions. After baseline measures of opioid craving, and other psychometrics, subjects will receive two unilateral t-PBM applications (810 nm CW LED, 250 mW/cm2, 60 J/cm2, 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment, the investigators will use 2 tests to determine which hemisphere is more associated with a negative outlook and cravings and will treat that side before the more positive hemisphere. The primary outcome measure will be an opioid craving scale (OCS). plus weekly Hamilton Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments. Patients will be closely monitored for any possible adverse side-effects from the treatment.

Conditions

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Opioid-use Disorder Depression, Anxiety Craving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Patients will come to the lab on 3 consecutive weekly visits. On the first, they go through the consent process and if signed, will have a clinical interview and ROS then be given baseline measures and then treated with transcranial photobiomodulation, following which they will undergo post-treatment measures. The treatment the first week will be randomized to active or sham and the second week they will receive the opposite treatment. The third week will be a follow-up of the second treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

One experimenter will act as the blinder and treater. Only he will know whether the patient receives the active or sham treatment and only he will prepare and provide the treatment. The patient and outcomes assessors will be blind to the treatment.

Study Groups

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Active

Patients will receive the active treatment.

Group Type ACTIVE_COMPARATOR

unilateral transcranial photobiomodulation, near infrared mode

Intervention Type DEVICE

The investigators are applying a supra luminous LED at 810 nm and 250 mW/cm2 to the forehead of the participant at F3 and F4.

Sham

Patients will receive the sham treatment (the identical LED covered by aluminum foil).

Group Type SHAM_COMPARATOR

Sham treatment

Intervention Type DEVICE

The sham treatment is identical to the active treatment except that the sham treatment has a piece of aluminum foil covering the led so that the participant will experience warmth but receive no photons.

Interventions

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unilateral transcranial photobiomodulation, near infrared mode

The investigators are applying a supra luminous LED at 810 nm and 250 mW/cm2 to the forehead of the participant at F3 and F4.

Intervention Type DEVICE

Sham treatment

The sham treatment is identical to the active treatment except that the sham treatment has a piece of aluminum foil covering the led so that the participant will experience warmth but receive no photons.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients complain of opioid cravings
* between the ages of 18 and 65.
* meet criteria for a history of opioid dependence by DSM V.

Exclusion Criteria

* a past history of a psychotic disorder (including schizophrenia or schizoaffective disorder)
* a history of violent behavior
* a history of a past suicide attempt
* a history of current suicidal ideation
* a history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), pregnancy,
* any current acute or chronic medical condition that might confound the study.
* Any patient judged by an investigator to have an impaired decision-making capacity

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No