CoLAB study schedule of assessments
| Study week | Screening | Treatment | Post-Tx | |||||||||||
| −4 to 0 | 0 | 4 | 8 | 12 | 16 | 20 | 24 | 28 | 32 | 36 | 40 | 44 | 48 | |
| Clinical assessments | ||||||||||||||
| Medical history and physical examination | X | |||||||||||||
| Substance use and treatment history | X | |||||||||||||
| Australian Treatment Outcome Profile (ATOP) | X | |||||||||||||
| Past 7 days sublingual buprenorphine dose | X | |||||||||||||
| Eligibility confirmation* | X | |||||||||||||
| Pregnancy test and contraception counselling† | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Urine drug screening‡ | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Concomitant medication review | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Dose adequacy | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Clinical Opiate Withdrawal Scale | X | X | X | When participant reports BUP-XR dose inadequacy or withdrawal, only | ||||||||||
| BUP-XR treatment | ||||||||||||||
| 300 mg BUP-XR injection | X | X | ||||||||||||
| 100 or 300 mg BUP-XR injection§ | X | X | X | X | X | X | X | X | X | X | ||||
| Telephone interviews | ||||||||||||||
| Demographics | X | |||||||||||||
| Subjective Opiate Withdrawal Scale | X | X | X | X | X | |||||||||
| Opioid Craving Scale | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Dose Adequacy | X | X | X | X | X | X | X | X | ||||||
| ATOP | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Overdose (self-report) | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Health service utilisation | X | X | X | X | X | |||||||||
| Australian Quality of Life four-dimension | X | X | X | X | X | |||||||||
| Pain, Enjoyment, General Activity scale | X | X | X | X | X | |||||||||
| Patient Health Questionnaire | X | X | X | X | X | |||||||||
| WHO Absenteeism and Presenteeism | X | X | X | X | X | |||||||||
| Treatment Satisfaction Questionnaire for Medication | X | X | X | X | X | |||||||||
| Treatment Perceptions Questionnaire | X | X | X | X | X | |||||||||
| End of Treatment Questionnaire | X | |||||||||||||
| Early Cessation Questionnaire | When participant has discontinued BUP-XR treatment early, for any reason | |||||||||||||
*Includes routine clinical tests where needed to confirm eligibility, forexample, suspected severe hepatic or renal impairment.
†In women of childbearing potential.
‡At 3 selected sites, for validation of participant-reported drug use during interviews.
§From the 3rd BUP-XR injection, the dose prescribed can be either 100 or 300 mg, at the discretion of the treating Investigator.
BUP-XR, extended-release buprenorphine; CoLAB, Community studies of Long-Acting Buprenorphine.