Background
Methods and materials
Participants and procedures
Data analysis
Results
Section/topic | Item no. | Checklist item | Reported on page no. |
---|---|---|---|
Title and abstract | |||
1a | Identification as a randomized trial in the title | 1 | |
1b | Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | 1 | |
Introduction | |||
Background and objectives | 1a | Scientific background and explanation of rationale | 2 |
2b | Specific objectives or hypotheses | 2 | |
Methods | |||
Trial design | 2a | Description of trial design (such as parallel, factorial) including allocation ratio | 2 |
2b | Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 2 | |
Participants | 2a | Eligibility criteria for participants | 2 |
2b | Settings and locations where the data were collected | 2 | |
Interventions | 2 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 2 |
Outcomes | 2a | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 2 |
2b | Any changes to trial outcomes after the trial commenced, with reasons | 2 | |
Sample size | 2a | How sample size was determined | 2 |
2b | When applicable, explanation of any interim analyses and stopping guidelines | NA | |
Randomization: | |||
Sequence generation | 2a | Method used to generate the random allocation sequence | 2 |
2b | Type of randomization; details of any restriction (such as blocking and block size) | 2 | |
Allocation concealment mechanism | 2 | Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | 2 |
Implementation | 2 | Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 2 |
Blinding | 2a | If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 2 |
2b | If relevant, description of the similarity of interventions | NA | |
Statistical methods | 2a | Statistical methods used to compare groups for primary and secondary outcomes | 2 |
2b | Methods for additional analyses, such as subgroup analyses and adjusted analyses | 2 | |
Results | |||
Participant flow (a diagram is strongly recommended) | 3a | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome | 2 |
3b | For each group, losses and exclusions afterrandomization, together with reasons | 3 | |
Recruitment | 3a | Dates defining the periods of recruitment and follow-up | 3 |
3b | Why the trial ended or was stopped | 3 | |
Baseline data | 3 | A table showing baseline demographic and clinical characteristics for each group | 3 |
Numbers analyzed | 3 | For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 3 |
Outcomes and estimation | 3a | For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | 3 |
3b | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 3 | |
Ancillary analyses | 3 | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | 3 |
Harms | 3 | All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | 3 |
Discussion | |||
Limitations | 6 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 3 |
Generalizability | 6 | Generalizability (external validity, applicability) of the trial findings | 6 |
Interpretation | 6 | Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 6 |
Other information | |||
Registration | 6 | Registration number and name of trial registry | 6 |
Protocol | 6 | Where the full trial protocol can be accessed, if available | 6 |
Funding | 6 | Sources of funding and other support (such as supply of drugs), role of funders | 6 |
Group | 32 mg n = 30 (33.33%) | 64 mg n = 30 (33.33%) | 96 mg n = 30 (33.33%) | Total n = 90 (100%) | Chi-square |
F
| df | p valuea | |
---|---|---|---|---|---|---|---|---|---|
Age (years)b “M (SD).” | 34.20 ± 7.30 | 32.83 ± 8.16 | 31.53 ± 5.035 | 32.85 ± 6.97 | 1.10 | 2 | 0.337 | ||
Drug abuse (years)b “M (SD).” | 9.75 ± 5.86 | 9.43 ± 6.52 | 10.50 ± 6.29 | 9.89 ± 6.17 | 0.232 | 2 | 0.794 | ||
Jobc “n (%)” | Unemployed | 12 (40) | 19 (63.3) | 14 (40) | 43 (47.8) | 8.719 | 6 | 0.190 | |
Employed | 2 (6.7) | 3 (10.0) | 2 (6.7) | 7 (7.8) | |||||
Self-employed | 16 (53.3) | 7 (23.3) | 16 (53.3) | 39 (43.3) | |||||
Educationc “n (%)” | Unable to read/write | 1 (3.3) | 1 (3.3) | 0 (0) | 2 (2.2) | 4.918 | 8 | 0.766 | |
Primary school | 11 (36.7) | 8 (26.7) | 10 (33.3) | 29 (32.2) | |||||
High school | 12 (40) | 17 (56.7) | 15 (50) | 44 (48.9) | |||||
University education | 6 (20) | 4 (13.3) | 4 (13.3) | 14 (15.6) | |||||
Marital statusc “n (%)” | Married | 15 (50) | 21 (70) | 14 (46.7) | 50 (55.6) | 3.870 | 2 | 0.144 | |
Single | 15 (50) | 9 (30) | 16 (53.3) | 40 (44.4) |
Group (Buprenorphine, mg) Day | 32 n = 30 | 64 n = 30 | 96 n = 30 |
---|---|---|---|
Baseline | 7.23 ± 3.51 | 6.93 ± 3.54 | 7.56 ± 3.53 |
Day 1 | 4.46 ± 3.95 | 4.96 ± 2.90 | 4.00 ± 2.75 |
Day 2 | 2.56 ± 3.23 | 3.03 ± 2.23 | 1.00 ± 1.74 |
Day 3 | 1.70 ± 2.39 | 0.900 ± 1.37 | 0.366 ± 0.927 |
Day 4 | 1.23 ± 1.86 | 0.300 ± 0.749 | 0.233 ± 0.727 |
Day 5 | 0.700 ± 1.14 | 0.100 ± 0.402 | 0.00 ± 0.00 |
Group | Baseline p value | Day 1 p value | Day 2 p value | Day 3 p value | Day 4 p value | Day 5 p value |
---|---|---|---|---|---|---|
32 vs 64 | 0.743 | 0.553 | 0.469 | 0.069 | 0.004 | 0.001 |
32 vs 96 | 0.716 | 0.579 | 0.017 | 0.003 | 0.002 | 0.000 |
64 vs 96 | 0.489 | 0.252 | 0.002 | 0.223 | 0.835 | 0.583 |