Trial · NCT06129916
Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB
NCT06129916, Not yet recruiting, PATH
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB. Trials, record NCT06129916. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06129916
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB
- NCT number
- NCT06129916
- Status
- Not yet recruiting
- Enrollment
- 760 participants, estimated
- Lead sponsor
- PATH
- Conditions
- Opioid Dependence
- Interventions
- long-acting depot buprenorphine (LADB)
- First posted
- 2023-11-13
- Last updated
- 2025-10-07
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Satisfaction Questionnaire for Medication 1.4 assessed through patient reported outcomes on effectiveness, side-effects, convenience and global satisfaction in relation to the medication | 48 weeks | The primary measure for treatment satisfaction will be collected through the Treatment Satisfaction Questionnaire for Medication 1.4 at 48 weeks. This is a generic measure of treatment satisfaction with medication. It has 14 questions divided into subscales (effectiveness; side effects, convenience and global satisfaction). Response are on a Likert-scale of 5 or 7 points except for 1 yes/no question on the presence of side effects. The scores are calculated for each of the subscales, which range from 0 to100 with higher scores indicating higher patient satisfaction with medication. |
| Primary | Retention in Care | 48 weeks | The primary measure for retention in care will be estimated as the proportion of people on LADB at 48 weeks |
| Primary | Nonmedical opioid use | 48 weeks | Assess degree of non-medical opioid use in the last month measured at week 48, in terms of number of days that non-medical opioids were not used in the last 4 weeks. |
| Secondary | % of participants who have received testing for HIV and Hepatitis C (HCV) at 48 weeks, frequency of testing, % testing positive for antibodies to HIV or HCV and % linked to treatment and % retained into treatment | 48 weeks | Retention into HIV treatment will be measured through self-report using a predefined threshold of adherence (80 to 100%) in consultation with sites as well as through recoding return visits for medication refills. Retention into HCV treatment will be measured as the proportion of those completing treatment and who have sustained virologic response 12 weeks after treatment. These data will be extracted from clinical records at programme sites. |
| Secondary | % of participants with self reported symptoms of depression at 48 weeks. | 48 weeks | Measured through the self-completion scale (PHQ-9 \[9-question Patient Health Questionnaire\] with scale from 0-3, lower score indicating better mental health |
| Secondary | % of participants with self-reported symptoms of anxiety at 48 weeks. | 48 weeks | Measured through the self-completion scale GAD-7 \[Generalized Anxiety Disorder 7) with scale from 0-3, lower score indicating better mental health |
| Secondary | % of participants reporting recent thoughts of or attempts at suicide at 48 weeks. | 48 weeks | This will be taken from other studies among people who inject drugs with "suicidality" specified as recent (within last 4 weeks) thoughts of and attempts at suicide. |
| Secondary | Patient-reported outcomes using the EuroQol measures of health status | 48 weeks | Patient-reported outcomes (PROMs) assessing health-related quality of life will include the EQ5D-5L, which measures the five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (range 1-5, lower score indicates better health) |
| Secondary | Patient-reported outcomes using the EuroQol visual analogue scale (EQVAS) | 48 weeks | Patient-reported outcomes (PROMs) assessing health-related quality of life using a visual analogue scale EQVAS (range 0-100, higher score indicates better health). |
| Secondary | % of participants reporting a non-fatal overdose in the last 6 months | 48 weeks | This will be defined as losing consciousness due to a drug-related overdose (opioids or ATS) in the last 6 months. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06129916
GET https://conductscience.org/api/trials/v1/NCT06129916/registered