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Completed

NCT Number: NCT04417738

Transcranial Photobiomodulation for the Treatment of Opioid Cravings

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MindLight, LLC

Newton Highlands, Massachusetts, 02461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

unilateral transcranial photobiomodulation, near infrared mode

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 treatment

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.

Primary outcomes

  1. Opioid Craving Scale, OCS

    Time frame: immediately before and after treatments and one week later

    A published scale that consists of 3 questions, each rated by the patient from 0 to 9. with 9 indicating severe cravings.

Secondary outcomes

  1. Hamilton Depression Rating Scale, HDRS

    Time frame: Before each treatment and 1 week later

    Standard depression rating scale; 0 to 53, a low score is less depressed. 0 to 7 is no depression.

  2. Hamilton Anxiety Rating Scale, HARS

    Time frame: Before each treatment and 1 week later

    A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety

  3. The Positive and Negative Affect Scale, PANAS

    Time frame: Before each treatment and 1 week later

    Patient rated positive and negative affects from 1 to 5. Five indicates extreme positive or negative affect. Scores for Positive and Negative Affects range from 0 to 25. A higher positive affect score and a lower negative affect score are better.

Sponsors and collaborators

Lead sponsor

MindLight, LLC

Industry

Registry information

Official study title

Unilateral Transcranial Photobiomodulation for the Treatment of Opioid Cravings: A Blinded Placebo-Controlled Evaluation of Efficacy and Safety

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2020
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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