Clinical trial NCT04417738: Transcranial Photobiomodulation for the Treatment of Opioid Cravings
Official title: Unilateral Transcranial Photobiomodulation for the Treatment of Opioid Cravings: A Blinded Placebo-Controlled Evaluation of Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Depression, Anxiety
Craving
Keywords: opioid craving
opioid use disorder
depression
anxiety
transcranial photobiomodulation
near infra-red light
dual-brain psychology
cerebral laterality
Lead sponsor: MindLight, LLC
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid Craving Scale, OCS
timeFrame: immediately before and after treatments and one week later
Secondary outcomes:
measure: Hamilton Depression Rating Scale, HDRS
timeFrame: Before each treatment and 1 week later
measure: Hamilton Anxiety Rating Scale, HARS
timeFrame: Before each treatment and 1 week later
measure: The Positive and Negative Affect Scale, PANAS
timeFrame: Before each treatment and 1 week later
Other outcomes:
Locations:
city: Newton Highlands
country: United States
facility: MindLight, LLC
state: Massachusetts
Study officials:
affiliation: MindLight, LLC
name: Fredric Schiffer
role: PRINCIPAL_INVESTIGATOR
References: