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1 1 Clinical Drug Investigation Evaluation of Buprenorphine Dosage Adequacy in Opioid Receptor Agonist Substitution Therapy for Heroin Dependence First Use of the Buprenorphine-Naloxone Dosage Adequacy Evaluation (BUDAVA) Questionnaire Antonio D Amore, et al. Supplemental Digital Content This Supplemental Digital Content contains the information referred to in the full version of this article, which can be found at Adis 2012 Springer International Publishing AG. All rights reserved.

2 2 BUDAVA (VAlutazione di Adeguatezza del Dosaggio di BUprenorfina/naloxone ) (assessment of buprenorphine/naloxone dosage adequacy) Introduction After confirming in clinical practice the validity of the ODAS assessment scale developed in Spain by González-Saiz et al. [1,2] and validated in Italy by a Scientific Validation Committee [3] as a tool for the systematic assessment of the adequacy of daily methadone dosage administered within a maintenance program, and as a consequence of the increasingly recognized role of buprenorphine in the long-term treatment of heroin addiction, we designed an assessment scale for buprenorphine similar to the ODAS scale. Our objective was the improvement of individualized treatment strategies with buprenorphine/naloxone. To account for the distinct mechanism of action of buprenorphine, the Additional items of the ODAS scale were modified. Description of the BUDAVA questionnaire The BUDAVA questionnaire is a clinical interview consisting of 13 questions that can be answered by closed, multiple-choice answers, or by means of a visual analogic scale (VAS), with five Likert-type options. The questions address the following issues: Use of heroin (Question 1); Narcotic blockade/cross-tolerance (Question 2); Frequency of opiate withdrawal syndrome (OWS) PHYSICAL area (Question 3); Intensity of the OWS PHYSICAL area (Question 4); Frequency of OWS PSYCHOLOGICAL area (Question 5); Intensity of OWS PSYCHOLOGICAL area (Question 6); Frequency of craving for heroin (Question 7); Intensity of craving for heroin (Question 8); Use of cocaine (Question 9); Intensity of craving for cocaine (Question 10); Frequency of overmedication (Question 11); Extent of overmedication (Question 12); Patient s subjective assessment of the adequacy of his/her current buprenorphine/naloxone dosage (Question 13). Each question obtains a score from 5 (best situation) to 1 (worse situation). These scores can be used to assess the adequacy of the buprenorphine dosage. The score of the BUDAVA questionnaire can be interpreted both quantitatively and qualitatively. For the quantitative interpretation, the sum of the scores of the 13 questions is calculated (total score range 13-65). Scores included in the range indicate inadequacy, while scores included in the range indicate that the treatment is adequate. For the qualitative interpretation, the individual domains assessed can be very useful for tailoring the treatment to patient s needs, for exploring other therapeutic approaches, or for integrating the treatment with psychosocial interventions, should the affected domains be the PHYSICAL or the PSYCHOLOGICAL area. The need to modify the dose of buprenorphine/naloxone according to the assessment provided by the BUDAVA questionnaire is a clinical decision which depends on a variety of factors that are addressed and evaluated, during the interview, by means of the five Additional items. The five Additional items do not contribute to the quantitative score. Our attention focused on the modification of these items, required to account for the mechanism of action of buprenorphine which is distinct from that of methadone. The BUDAVA questionnaire was designed to assess the adequacy of the buprenorphine/naloxone dosage taken in the previous seven s, in patients in treatment for at least 6 months with a mean daily dosage of 8-24 mg. For completeness, the control of morphine blood levels was included, to be performed at the first interview and repeated at the second interview after 15 s, in case of inadequate dosage.

3 3 BUDAVA Valutazione di Adeguatezza del Dosaggio di BUprenorfina/naloxone (assessment of buprenorphine/naloxone dosage adequacy) Date of the interview: / / Patient first and last name: Buprenorphine/naloxone dosage taken during the last week: mg/ Time in current treatment program with buprenorphine/naloxone: weeks Frequency of use of other drugs during the last week (indicate the number of s of use): Alcohol s Cannabis s Benzodiazepines s Amphetamines s Other (specify): s s s

4 4 1. Use of heroin During the last 7 s, how frequently did you take heroin? Never From one to three s per week From four to six s per week From once to three times per Score Three times or more per CUT-OFF POINT: If the patient never took heroin during the last week, proceed to question 3. Give a score of 5 to questions 1 and Narcotic blockade / cross-tolerance How intense was the effect produced by the dose(s) of heroin you took during the last seven s? Your buprenorphine/naloxone dosage during the last seven s was milligrams per. Did you feel the effect of the dose(s) of heroin? If you did, how intense was the effect? Was the effect different from what you experienced when you were not in treatment with buprenorphine/naloxone? Was the effect different from what you experienced when you were taking a different buprenorphine/naloxone dosage? SCORE: Show Chart 1 to the patient. The score is obtained by inverting the value on the VAS scale of Chart 1, according to the table for VAS score conversion. 3. Frequency of opiate withdrawal syndrome PHYSICAL area During treatment with buprenorphine/naloxone, some people suffer from disturbances including: cramps and muscular pain, goosebumps, runny nose, watery eyes, frequent yawning, stomach cramps or diarrhea, palpitations, sweating, and general discomfort. During the last 7 s, how frequently did you experience any of these disturbances? Never From one to three s per week From four to six s per week From once to three times per Three times or more per

5 5 Score (To establish clinically the presence of OWS belonging to the PHYSICAL area, the patient should present at least two or more signs and/or symptoms reported in the main question, unless the interviewer identifies other clinical conditions belonging to the PHYSICAL area which confirm the presence of OWS). CUT-OFF POINT: If the patient never experienced during the last week at least two of these disturbances, proceed to question 5 and give a score of 5 to questions 3 and Intensity of opiate withdrawal syndrome PHYSICAL area During the last seven s, on average, how intense were the disturbances experienced? When you experienced these disturbances, how intense were they on average? SCORE: Show Chart 2 to the patient. The score is obtained by inverting the value on the VAS scale of Chart 2, according to the table for VAS score conversion. 5. Frequency of opiate withdrawal syndrome PSYCHOLOGICAL area During treatment with buprenorphine/naloxone, some people experience disturbances including: anxiety, agitation, irritability, sleep problems, tiredness, shivers, muscular pain, lack of appetite. During the last 7 s, how frequently did you experience any of these disturbances? Never From one to three s per week From four to six s per week From once to three times per Score Three times or more per (To establish clinically the presence of OWS belonging to the PHYSICAL area, the patient should present at least two or more signs and/or symptoms reported in the main question, unless the interviewer identifies other clinical conditions belonging to the PHYSICAL area which confirm the presence of OWS). CUT-OFF POINT: If the patient never experienced during the last week at least two of these disturbances, proceed to question 7 and give a score of 5 to questions 5 and Intensity of opiate withdrawal syndrome PSYCHOLOGICAL area

6 6 During the last seven s, on average, how intense were the disturbances experienced? When you experienced these disturbances, how intense were they on average? SCORE: Show Chart 2 to the patient. The score is obtained by inverting the value on the VAS scale of Chart 2, according to the table for VAS score conversion. 7. Frequency of craving for heroin During the last 7 s, how frequently did you feel an urgent need or a strong desire to take heroin? Never From one to three s per week From four to six s per week From once to three times per Score Three times or more per CUT-OFF POINT: If the patient never experienced craving for heroin during the last week, proceed to question 9 and give a score of 5 to questions 7 and Intensity of craving for heroin During the last seven s, on average, how intensely did you feel an urgent need to take heroin? When you wanted to take heroin, how intense was this need on average? SCORE: Show Chart 2 to the patient. The score is obtained by inverting the value on the VAS scale of Chart 2, according to the table for VAS score conversion. 9. Use of cocaine During the last 7 s, how frequently did you take cocaine? Never From one to three s per week From four to six s per week From once to three times per Score Three times or more per

7 7 CUT-OFF POINT: If the patient never took cocaine during the last week, proceed to question 11 and give a score of 5 to questions 9 and Intensity of craving for cocaine During the last seven s, on average, how intensely did you feel the need to take cocaine? When you wanted to take cocaine, how intense was the need on average? SCORE: Show Chart 2 to the patient. The score is obtained by inverting the value on the VAS scale of Chart 2, according to the table for VAS score conversion. 11. Frequency of overmedication During treatment with buprenorphine/naloxone, some people can experience symptoms including: drowsiness or the sensation of being sleepy/ slowed down, speech impairment, unusual activity, or alternatively, the sensation of being on drugs. (Ask the patient whether these symptoms occurred about 3 hours after taking buprenorphine/naloxone.) During the last 7 s, how frequently did you experience any of these symptoms? Never From one to three s per week From four to six s per week From once to three times per Score Three times or more per CUT-OFF POINT: If the patient has never experienced any of these symptoms, proceed to question 13 and give a score of 5 to questions 11 and Extent of overmedication During the last week, on average, how intense were the symptoms that you mentioned in your previous answer? When you experienced these symptoms, how intense were they on average? SCORE: Show Chart 2 to the patient. The score is obtained by inverting the value on the VAS scale of Chart 2, according to the table for VAS score conversion.

8 8 13. Patient s subjective assessment of the adequacy of his/her current buprenorphine/naloxone dosage Do you feel that your current buprenorphine/naloxone dosage is adequate for you? A dosage is adequate when it makes you feel covered (that is, free from any withdrawal symptom) and significantly reduces your desire to take heroin, without making you feel as if you were on drugs. SCORE: Show Chart 3 to the patient.

9 9 ADDITIONAL ITEMS A. Patient s wish to modify his/her buprenorphine/naloxone dosage Which buprenorphine/naloxone dosage would you like to take over the next seven s? Indicate one of the followings: Patient wants to continue with the same dosage Patient wants to increase dosage to mg/ Patient wants to decrease dosage to mg/ B. Modality of medication administration Time C. Side effects of buprenorphine/naloxone taken during the last 7 s During the last 7 s which of the following symptoms did you experience? Read the list to the patient and mark with X the symptoms confirmed. Headache Increased sweating Sleep problems Anxiety Depression Nervousness Gastrointestinal disturbances Constipation Yes No D. Concomitant medication taken during the last 7 s Active ingredient Total daily dosage E. Degree of patient s functioning: GAF-DSM-IV Scale [4]

10 10 ANNEX 1 Analogic visual scales Chart 1: Indicate on this scale from 1 to 5 the intensity of the effect of the heroin dose(s): No effect at all Extremely strong effect Table for conversion of VAS scores VAS Points Chart 2: Indicate on this scale from 1 to 5 the intensity degree: Nothing at all Extremely intense Table for conversion of VAS scores VAS Points Chart 3: Indicate on this scale to what extent you consider adequate for you the dosage you are currently taking: Totally inadequate Totally adequate No conversion table for these VAS scores.

11 11 ANNEX 2 Interpretation of BUDAVA scores Quantitative interpretation: Total: Assign a score from 1 to 5 Range of total points Inadequate dosage points Adequate dosage points The total score of the BUDAVA questionnaire is the weighted sum of the scores of all 13 questions. The total score falls within the range going from 13 to 65 points. Qualitative interpretation: The dosage is considered adequate when each one of the 13 questions of the BUDAVA questionnaire scores 4 or 5. If this condition is not met, the dosage is considered inadequate. It is important to identify the domains of inadequacy (physical and psychological areas). The table for score recording is below.

12 12 Table for recording the scores of the BUDAVA questionnaire Questions Question 1 Use of heroin Question 2 Narcotic blockade/cross tolerance Question 3 Frequency of OWS (Physical area) Question 4 Intensity of OWS (Physical area) Question 5 Frequency of OWS (Psychological area) Question 6 Intensity of OWS (Psychological area) Question 7 Frequency of craving for heroin Question 8 Intensity of craving for heroin Question 9 Use of cocaine Question 10 Intensity of craving for cocaine Question 11 Frequency of overmedication Question 12 Extent of overmedication Question 13 Patient s subjective assessment of dosage adequacy TOTAL OWS, opiate withdrawal syndrome

13 13 ANNEX 3 Results of toxicology tests Date of first test /-- --/ Positive: opioids cocaine methadone benzodiazepines cannabis Negative Date of second test /-- --/ Positive: opioids cocaine methadone benzodiazepines cannabis Negative

14 14 ANNEX 4 Global Assessment of Functioning (GAF) Scale [4] Consider psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness. Do not include impairment in functioning due to physical (or environmental) limitations. (Note: Use intermediate codes when appropriate, e.g. 45, 68, 72.) Superior functioning in a wide range of activities, life s problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. No symptoms Absent or minimal symptoms (e.g. mild anxiety before an exam), good functioning in all areas, interested and involved in a wide variety of activities, socially effective, generally satisfied with life, no more than every problems and concerns (e.g. an occasional argument with family members) If symptoms are present, they are transient and expectable reactions to psychosocial stressors (e.g. difficulty concentrating after family argument); no more than slight impairment in social, occupational and school functioning (e.g. temporarily falling behind in schoolwork) Some mild symptoms (e.g. depressed mood and mild insomnia); OR some difficulty in social, occupational, or school functioning (e.g. occasional truancy, or theft within the household), but generally functioning pretty well; has some meaningful interpersonal relationships Moderate symptoms (e.g. flat affect and circumstantial speech, occasional panic attacks); OR moderate difficulty in social, occupational, or school functioning (e.g. few friends, conflicts with peers or co-workers) Serious symptoms (e.g. suicidal ideation, severe obsessional rituals, frequent shoplifting); OR any serious impairment in social, occupational, or school functioning (e.g. no friends, unable to keep a job) Some impairment in reality testing or communication (e.g. speech is at times illogical, obscure, or irrelevant); OR major impairment in several areas, such as work or school, family relations, judgment, thinking, or mood (e.g. depressed man avoid friends, neglect family and is unable to work; child frequently beats up younger children, is defiant at home, and is failing at school) Behaviour is considerably influenced by delusions or hallucinations; OR serious impairment in communication or judgment (e.g. sometimes incoherent, acts grossly inappropriately, suicidal preoccupation); OR inability to function in almost all areas (e.g. stays in bed almost all ; no job, home, or friends) Some danger of hurting self or others (e.g. suicide attempts without clear expectation of death; frequently violent; manic excitement); OR occasionally fails to maintain minimal personal hygiene (e.g. smears feces); OR gross impairment in communication (e.g. largely incoherent or mute) Persistent danger of severely hurting self or others (e.g. recurrent violence); OR persistent inability to maintain minimal personal hygiene; OR serious suicidal act with clear expectation of death. 0 Inadequate information.

15 15 References 1. González-Saiz F. Opiate Dosage Adequacy Scale (ODAS): a clinical diagnostic tool as a guide to dosing decisions. Heroin Addict Relat Clin Probl 2004; 6(3): González-Saiz F, Rojas OL, Gómez BR, et al. Evidence of reliability and validity of the Opiate Dosage Adequacy Scale (ODAS) in a sample of methadone maintenance patients. Heroin Addict Relat Clin Probl 2008; 10(1): Bignamini E, Carboni G, D Egidio PF, et al Validazione culturale e linguistica del questionario EADO (ODAS) utilizzato per definire l adeguatezza del dosaggio giornaliero di metadone nel contesto di un programma di mantenimento per il trattamento della dipendenza da oppiacei. Mission 2008; 26(6): Diagnostic and statistical manual of mental disorders, 4th edition, text revision (DSM-IV-TR, 2000); published by the American Psychiatry Association (APA)