Table 1 Summary of all clinical and social outcomes used to establish effectiveness for trials in opioid addiction
Domains | Outcomes | Subdomains | Measurement of Outcome |
|---|---|---|---|
Abstinence and substance use behavior | Illicit opioid use | Frequency of illicit opioid use (mean number of negative opioid urine screens or percentage of positive opioid screens, days of illicit use, assessed per treatment arm) | Urine toxicology screening |
A composite score from the Addiction Severity Index (European version) | |||
Self-report | |||
Hair sample toxicology screening | |||
Scores from Addiction Severity Index (American interview) domain assessing number of days of opiate use in last month | |||
Visual analog scale (daily heavy drug abuse was recorded as 10 and ‘drug free’ was recorded as 0) | |||
Weekly activity summary (WAS) | |||
‘Dirty rate’ measured using the number of opiate-positive urine screenings divided by the number of weeks of study participation | Urine toxicology screening | ||
Time to relapse measured using the number of days between baseline and occurrence of the first opiate-positive urine screening | Urine toxicology screening | ||
Failure to maintain abstinence | Urine toxicology screening | ||
Heroin use in preceding month at 3-, 6-, and 12-month interviews | Self-reported frequency of use measured using the Opiate Treatment Index | ||
Response to treatment measured as a reduction of regular use of street heroin, which was defined as 50% or more of negative specimens on urinalysis during weeks | Urine toxicology screening | ||
Percentage of patients in a drug free period, defined as time elapsed between the first day of naltrexone administration and the first evidence of opiate abuse (day on which positive urine test for opiate was obtained, or alternatively, the day on which the patient reported on opiate abuse) | Urine toxicology screening | ||
Abstinence from street heroin (zero use) in the past 30 days | Self-reported abstinence obtained by independent researchers in face-to-face interviews | ||
Assessment of near (< 2 opioid positive urine screens) and full abstinence (0 opioid positive urine screens) | Urine toxicology screening | ||
Percentage of participants per treatment arm who maintained 12 consecutive opioid-free urine screens | Urine toxicology screening | ||
Slip defined as occasional heroin use, less than three consecutive positive urine screens, and no symptoms of withdrawal | Self-report and urine toxicology screening | ||
Days to heroin relapse (three consecutive opiate-positive urine screens) | Urine toxicology screening | ||
Number of days a patient could remain abstinent measured by the longest duration of opiate negative urine screen | Urine toxicology screening | ||
Drug use history and routes of substance abuse | Risk Behaviour Survey | ||
The global severity of all aspects of their current drug problem | Self-report on a scale of 0 (no problem) to 100 (very severe) | ||
Opioid relapse defined as everyday heroin use, three consecutive positive urine tests, or reported symptoms of withdrawal | Self-report and urine toxicology screening | ||
Degree of opioid substance abuse | Global rating scale: rating of 2 marked an improvement in rehabilitation and substance use | ||
Non-opioid Substance Use | Frequency of poly-substance use (e.g., percentage/mean number of positive stimulants/benzodiazepines urine screens per treatment arm cocaine, benzodiazepines, illicit methadone) | Self-report | |
Reported by family members or friends watching the participant | |||
Weekly activity summary (WAS) | |||
Visual analog scale (daily heavy drug abuse was recorded as 10 and ‘drug free’ was recorded as 0) | |||
Weekly Drug Use Questionnaire | |||
Urine toxicology screening | |||
Days of alcohol use per treatment arm | Self-report | ||
Severity of nicotine dependence | The Fagerström Test for Nicotine Dependence | ||
Alcohol consumption | Breathalyzer test | ||
The global severity of all aspects of their current drug problem | Measured on a scale of 0 (no problem) to 100 (very severe) | ||
Drug use history and routes of substance abuse | Risk Behaviour Survey | ||
Health risk behavior related to substance use | Injecting drug-use behavior | Self-report | |
Reduction in HIV risk behaviors | AIDS risk inventory | ||
Opiate Treatment Index | |||
Risk Assessment Battery (RAB) scores | |||
Maudsley Addiction Profile | |||
Money spent or gained on illicit opioid consumption | Amount of money spent on illicit opioid consumption per month | Addiction Severity Index | |
Amount of money gained from illicit opioid consumption per month | Addiction Severity Index | ||
Physical health | Drug cravings | Craving for opioid substances | Subjective Opiate Withdrawal Scale, German version |
Visual Analog Scale for Heroin Craving | |||
Craving Visual Analogue Scale (CVAS; administered every week): a 10 cm line—with an end corresponding to 0 and the other to 100—was used to record the extent of subjective cravings for heroin, cocaine. and alcohol in the preceding week | |||
Tiffany Heroin Craving Questionnaire | |||
Overdose | Overdose of illicit or prescribed opioid and non-opioid substances requiring medical attention | Self-report | |
Medical chart review | |||
Withdrawal Symptoms | Opioid physical withdrawal symptoms | The Withdrawal Symptoms Checklist | |
Self-reported euphoric feelings | |||
The Addiction Severity Index | |||
Subjective Opiate Withdrawal Scale (German version: SOES) | |||
Self-report | |||
The Wang Scale | |||
Addiction Research Centre Inventory | |||
General physical health | General physical health and well-being, an assessment of current physical symptoms, physical functioning, physical role limitations, bodily pain, physical comorbidity, as well as medical history | Opioid Treatment Index | |
Quality of Life scale (SF-12) | |||
Self reported health measured assessing symptoms, overdoses, and mortality | |||
Maudsley Addiction Profile | |||
Short Form 36-item Health Survey | |||
Physicians perception of disease severity and overall improvement compared to baseline | Clinical Global Impressions Scale, German Version | ||
Immune system functioning | Plasma concentrations of TNF-alpha, IL-2 beta, IL-1beta and CD14 lymphocyte | ||
Cardiac function assessed with corrected QT interval measurements | Electrocardiographic analysis | ||
Evaluation of patients meetings the categorical QTc prolongation thresholds across treatment groups (e.g., more than 470 ms for males and more than 490 ms for females) | Electrocardiographic analysis | ||
Psychiatric health and symptoms | Psychiatric symptoms | Psychiatric assessment for depression, anxiety, and other psychiatric symptoms | Mental health symptoms measured using the SF-12 |
Symptom checklist-90 (SCL-90) | |||
Short Form 36-item | |||
Self-rating Depression (SRD) questionnaire | |||
Minnesota Multifactorial Personality Inventory (MMPI) | |||
Symptom checklist (SCL-5) | |||
The Beck Depression Inventory | |||
State Trait Anxiety Inventory (STAI) | |||
Sensation Seeking Scale (SSS) | |||
Addiction Severity Index | |||
Maudsley Addiction Profile | |||
Scale of Anhedonia syndrome | |||
Self-reported assessments (somatization, depression, hostility, anxiety, paranoid ideation, interpersonal sensitivity) | |||
Psychological adjustment | Psychological and social adjustment | Addiction Severity Index (family and social relations scores) | |
Opiate Treatment Index (social functioning scores) | |||
Clinical Global Impression as assessed by the Brief Psychiatric Rating Scale | |||
Global quality of life and addiction severity assessments (outcomes of combined domains) | Composite addiction severity scores | Composite scores from addiction severity assessments that encompass patients physical, psychological, and social functioning, as well as their substance use behavior | Composite International Diagnostic Interview |
European Addiction Severity Index | |||
Addiction Severity Index | |||
Global quality of life | Quality of life assessment encompasses the evaluations of physical, social, physical, and psychological well-being | SCL-90-R subscales | |
SCL-90-R global scores | |||
General Symptomatic Index | |||
Positive Symptom Total | |||
Positive Symptom Distress Index | |||
Lancashire Quality of Life Profile | |||
Visual analog scale (10 = very bad, 0 = very well) and with the temporal satisfaction with life scale (TSLS) | |||
Personal and social functioning | Criminal behavior | Involvement in illegal activity | Self-reported days involved in illegal activities |
Self-reported time spent with people still abusing substances, selling drugs, engaging in illegal activity | |||
Lifestyle Changes Questionnaire (patients indicated whether they had engaged in any of nine activities to stop, reduce, or avoid cocaine/heroin use during the past week and whether they had committed crimes) | |||
Weekly Activity Summary (WAS 42) | |||
Employment and social involvement | Social stability assessed using current employment, volunteer, or social activities | Self-reported changes in vocational and social rehabilitation | |
Self-reported consumption of meals, type of accommodation, and current employment activities | |||
Weekly Activity Summary (WAS 42) | |||
Behavioral observation where the research assistant recorded (yes/no) if patients had initiated new activities or increased the amount of time spent in any of three activity categories: (1) employment; (2) family/social; and (3) personal (spiritual, counseling or psychotherapy, physical fitness) | |||
Participation in non-study related addiction treatment programs (Narcotics Anonymous, etc.) | |||
Relationships | Evaluation of relationships and personal conflict with others | Personal and social functioning domain of the Maudsley Addiction Profile | |
Social functioning measured using SF-36 health survey | |||
Personal and social function measured by self-reported time spent with people still abusing substances, selling drugs, engaging in illegal activity | |||
Personal stability | Evaluation of personal stability through assessment of housing and food consumption | Self-reported consumption of meals and type of accommodation | |
Resource utilization | Service utilization | Evaluation of how patients utilize available treatment and social services | Days patients were seen by counselors |
Total clinic attendance | |||
Intervention adherence | Retention in treatment | Number of patients remaining on the allocated intervention at the end of follow-up | Adjudicated by the trial research staff |
Number of patients remaining on the allocated intervention and maintained a standard of opioid-free urine set by the study coordinators at the end of follow-up | Adjudicated by the trial research staff | ||
Time until patient withdraws from treatment | Adjudicated by the trial research staff | ||
Intervention compliance | Days patients attended clinic as an assessment of how well patient adheres to the treatment regime | Adjudicated by the trial research staff | |
Treatment attendance, the number of days medicated divided by days in treatment | |||
Involvement of a significant other in treatment who was asked to supervise and report on compliance at each study visit, either in person or by telephone | |||
Assessment of medication adherence (evaluation of whether patient takes the medication prescribed) | Visual inspection of urine, inclusion of riboflavin 50 mg in the active and placebo naltrexone capsules with visual inspection for its presence using ultraviolet light at the long wave setting (444 nm) in a room with low ambient light | ||
Count of remaining capsules at each appointment | |||
Study patients were required to respond to a random medication recall once each 4 weeks to monitor and deter potential misuse of methadone | |||
Involvement in services provided by treatment centers | Assessment of the counseling visits, which was based on the length (minutes) and number of contacts the patient had with either individual or group treatments | ||
Successful medication induction | At least one dose of medication by the sixth day of the study | Assessed by clinical research staff | |
Intervention acceptance | Intervention preference | Assessment of final drug of choice (at end of cross-over trial participants could chose which therapy to remain on) | Self-report |
Medication preferences (includes a proxy assessment of dosing adequacy) | The Helping Alliance Questionnaire II (HAq-II; patient version), a 19-question self-administered instrument that measures the quality of therapeutic alliance between patients and therapists from the point of view of the patients | ||
The Client Satisfaction Questionnaire (CSQ), a self-administered questionnaire that assesses overall satisfaction with treatment | |||
Measured using a visual analogue questionnaire of drug properties which required them to “rate each drug on six different factors: is the drug holding (suppressing withdrawal); how much buzz do you get from the drug; do you experience side effects; do the side effects bother you; do you like the drug; and do you feel more normal?” |