Craving, Depression, Anxiety, Opioid-use Disorder
Conditions
Keywords
opioid craving, opioid use disorder, depression, anxiety, transcranial photobiomodulation, near infra-red light, dual-brain psychology, cerebral laterality
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.
Interventions
DEVICEunilateral 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.
DEVICESham 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.
Sponsors
MindLight, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Craving Scale, OCS | 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
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale, HDRS | 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. |
| Hamilton Anxiety Rating Scale, HARS | Before each treatment and 1 week later | A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety |
| The Positive and Negative Affect Scale, PANAS | 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. |
Countries
United States
Outcome results
None listed