(23) Patient Attitudes Toward Open Label Placebo Treatment for Opioid Use Disorder

Introduction:

Placebo effects can be harnessed for therapeutic value in a wide variety of diseases including substance use disorders (1,2). Placebos are drugs, devices, or other treatments that are physiologically and pharmacologically inert. Placebo effects may be particularly applicable in opioid use disorder (OUD) due to the significant involvement of the endogenous opioid system in placebo responses in pain management (3, 4).

Traditionally, the dogma has been that for placebos to work, patients must believe they are receiving active medication—a form of deception that compromises the patient-provider relationship. Several studies challenge that notion, however, reporting the effectiveness of open label placebo (OLP) administration in the treatment of a wide array of conditions (5). These studies have garnered attention for OLP as a credible method of treatment, since it does not involve active deception or coercion(6). Currently there is no scientific literature exploring patient attitudes towards OLP obtained in a clinical trial involving OLP treatment. The goal of this study was to analyze qualitative data regarding patient experience of treatment with OLP obtained within a randomized controlled clinical trial of OLP dose extending placebo for opioid use disorder.

Methods:

The parent study consisted of 120 newly enrolled treatment-seeking patients with OUD who were randomly assigned to one of two different groups: either methadone plus OLP or methadone treatment as usual (NCT02941809). Our qualitative study was embedded within the OLP arm.
36 of the 45 participant in the OLP group voluntarily completed an exit survey. Responses were written by hand and transferred to REDCap using a double-blind verification process. To ensure inter-coder reliability two coders analyzed the responses separately to create a code book. Codes were developed using a semantic approach and double-coding of responses occur for each question.
Results

Participants were asked whether receiving OLP pills was helpful for their treatment. 30 of 36 participants (83%) indicated that the pills were helpful. Within those who reported that OLP was helpful for treatment, subthemes emerged concerning “establishing a routine” and “reduction and craving and withdrawal symptoms.”

Lastly, participants receiving OLP pills were asked if they would recommend OLP pills to other people being treated with methadone for OUD. 34 of 36 participants (94%) stated that they would recommend OLP pills to other people being treated with methadone. Of the 32 coded responses, major themes of “it’s worth a try”, “it helped me,” and “improvements in clinical outcomes” emerged. Additionally, a minor theme of “it didn’t help me, but could help someone else” was observed.

Discussion:

Subjects with OUD receiving OLP found it to be an acceptable and favorable adjunct to methadone treatment as usual. Also, subjects found administration of open label placebo to be suitable for recommendation as adjunct treatment of OUD. These data suggest further exploration of OLP as an adjunct to methadone treatment for OUD.

References: 1) De Saintonge, DM Chaput, and Andrew Herxheimer. "Harnessing placebo effects in health care." The Lancet 344.8928 (1994): 995-998.

2) Belcher, A. M., Ferré, S., Martinez, P. E., & Colloca, L. (2018). Role of placebo effects in pain and neuropsychiatric disorders. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 87, 298-306.

3) Levine JD, Gordon NC, Fields HL. The mechanism of placebo analgesia. Lancet. 1978 Sep 23; 2(8091):654-7. doi: 10.1016/s0140-6736(78)92762-9. PMID: 80579.

4) Benedetti F. The opposite effects of the opiate antagonist naloxone and the cholecystokinin antagonist proglumide on placebo analgesia. Pain. 1996 Mar;64(3):535-543. doi: 10.1016/0304-3959(95)00179-4. PMID: 8783319.

5) Charlesworth JEG, Petkovic G, Kelley JM, et al. Effects of placebos without deception compared with no treatment: a systematic review and meta-analysis.J Evid Based Med 2017;10:97–107.

6) Finniss, D. G., Kaptchuk, T. J., Miller, F., & Benedetti, F. (2010). Biological, clinical, and ethical advances of placebo effects. The Lancet, 375(9715), 686-695.