Harnessing Placebo Effects in Methadone Treatment

Mean dose of methadone at 3 months (90 days) post-baseline (entry into treatment) will be evaluated for each of the two arms.

Three-month (90-day) and 6-month (180 day) treatment retention as a binomial (yes/no) variable outcome

Total number of days retained in methadone treatment, up to 365 days

Number of days of self-reported drug use will be obtained at all five study meetings time points (baseline, 2-weeks post-baseline, and 1-, 2-, and 3-months post-baseline) for each of the following substances: opiates, cocaine, benzodiazepines, alcohol, and a single, all-encompassing category of "other drug use".

Urine toxicology screening via a point of care Quik-tox screen- panel of 13 drugs to determine the presence (positive/negative) of Cocaine, Opiates, Methamphetamine, Cannabis, Amphetamines, Phencyclidine, Benzodiazepines, Barbiturates, Methadone, Oxycodone, MDMA, Buprenorphine, and Fentanyl.

An adapted one-item visual-analogue scale to assess drug craving. The scale ranges from 0-100 (0- craving not at all, 50- neutral, 100- Very much).

A 13-item clinical assessment of physiological signs of withdrawal conducted by the investigator or a research team member. Scores of 0-1 are given for each item and scores are summed ranging from 0-13.

A 16-item patient self-report instrument to assess common subjective symptoms of craving and withdrawal. Scores of 0-4 are given for each item and total scores are summed ranging from 0-64.

A 19-item validated tool to assess sleep quality. The 19 self-rated items are combined to form 7 "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The 7 component scores are then added to added a global score, with a range of 0-21 points.

The WHOQOL-BREF is a 26-item assessment that produces a quality of life profile with four domain scores and two items that are examined separately. The mean score of items within each domain is used to calculate the domain score, which are then transformed to scale scores. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.

The PCS is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 0-52. The higher the score, the more catastrophizing thoughts are present. A cutoff of more than 30 points is considered to be clinically relevant.

Compliance: a visual-analogue scale rating from 0-100 assessing compliance with instructions to take the placebo pill; higher numbers indicate greater compliance.

The Methadone Side Effects Checklist (Longwell B, Kestler RJ & Cox TJ, 1979) assesses severity of of 38 commonly reported methadone treatment-associated side effects. 38 symptoms are rated 1-5 (1="no problem at all"; 5="a very bad problem") for a total possible score of 38-190. Higher total scores indicate higher severity of symptoms.

The CCCS (Agachan, Chen, Pfeifer, Reissman, Wexner, 1996) is an 8-item scale of self-reported severity of symptoms of constipation. A total score is derived, with a possible score of 0-32. Higher total scores indicate higher severity of symptoms.

A single-item visual analog scale (0-100) assessment of participant beliefs that the placebo pill would improve symptoms of addiction. Higher scores indicate greater belief/expectation of a beneficial placebo pill effect.

The MCQ (Kirby & Marakovic, 1996) is a 27-item assessment of delay discounting. For each item, the participant chooses between a smaller, immediate monetary reward and a larger, delayed monetary reward. The protocol is scored by calculating where the respondent's answers place him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of impulsivity.

The BIS-11 (Patton, Stanford, Barratt, 1995) is a 30-item assessment that yields information regarding three facets of trait impulsivity (ie, attentional impulsivity, motor impulsivity and non-planning impulsivity). Participants indicate on a four-point Likert-like scale the extent to which each of 30 items describes their overall behavior. A scoring algorithm (with some items reverse-scored) yields 6 first-order and 3 second-order factors, as well as an overall score (a total possible score of 120). Higher values on each of the factors indicate higher levels of impulsivity.

A 7-item quantitative and qualitative assessment of how the placebo pill was experienced by participants and their thoughts about their experience participating in the study.