Perinatal EvidenceCompass
Prepopulated workbenchMED-240

Substance-use disorder — stimulant

Bupropion plus naltrexone regimen

Off-label/investigational pharmacotherapy for stimulant use disorder

Not a categorical safety rating

This record organizes questions; it does not close them.

The clinical fields and position statements are prepopulated from the public-source corpus. They have not completed individual dual extraction, formal appraisal, exact-label reconciliation, or multidisciplinary sign-off. Do not use this page to justify abrupt discontinuation or reflexive switching.

Inventory identity

What this record represents

Canonical generic name
Bupropion plus naltrexone regimen
Entity type
multi-drug regimen
Active component(s)
Bupropion · naltrexone
Formulation / route / interval
Studied regimen uses separate agents/formulations; not a universally approved stimulant-use-disorder product
Attachment entry
Bupropion plus naltrexone
Separate monograph status
Yes — regimen plus component cross-references
Identity and cross-reference
Do not equate the studied regimen automatically with the fixed-dose obesity product naltrexone/bupropion (Contrave)
Inventory verification confidence
Moderate — molecule-level source; exact product/jurisdiction pending

Decision taxonomy

Five positions kept separate

These are workbench statements for reviewer execution. They are not independently commissioned, patient-specific recommendations.

  1. 01

    Stable continuation

    Workbench statement

    Do not withhold or discontinue solely because of pregnancy or lactation. For this record, assess indication, prior response, relapse severity, dose/formulation, alternatives, exposure timing, and mapped evidence; individual commissioned adjudication remains pending.

  2. 02

    New initiation in pregnancy

    Workbench statement

    For a new start, prefer an effective option with the strongest diagnosis-specific efficacy and reproductive evidence when clinically suitable. This record has not received an individual, independently verified initiation ranking.

  3. 03

    Switch before conception

    Workbench statement

    Before conception, consider a switch only when expected benefit exceeds relapse, withdrawal, failed-switch, and dual-exposure risks. Build and monitor the plan before pregnancy when feasible; no universal switch direction is assigned here.

  4. 04

    Unplanned exposure

    Workbench statement

    After unplanned exposure, confirm product, route, dose, timing, indication, co-exposures, and symptoms; do not advise abrupt cessation. Use the mapped evidence and current label to decide whether any targeted fetal assessment is indicated.

  5. 05

    Delivery, postpartum & lactation

    Workbench statement

    Create separate delivery, postpartum-dose, neonatal-observation, and lactation plans. Do not infer breastfeeding suitability from pregnancy evidence or routinely taper before delivery without drug-specific support.

Linked evidence

2 mapped claim summaries

Mapping can include class-wide, framework, formulation, regulatory, or evidence-gap claims. A linked claim is not necessarily a drug-specific causal estimate.

C-024Provisional public source

No medication is FDA-approved for stimulant-use disorder; contingency management is the current standard behavioral intervention, while off-label medicines require specialist selection.

Public-source certainty descriptor
High guideline consensus; not GRADE-rated here
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
Pregnancy and nonpregnant treatment
Comparator
Behavioral standard versus off-label pharmacotherapy
Effect or numbers carried forward

No approved pharmacologic effect estimate

Limitations

Access to contingency management varies; guideline medication evidence is mainly nonpregnant

Sources, citation controls, and verification state

Linked sources

PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
C-025Provisional public source

In ADAPT-2, nonpregnant adults receiving bupropion plus extended-release naltrexone had a higher but modest response rate than placebo; pregnant participants were excluded.

Public-source certainty descriptor
Moderate for selected nonpregnant adults; no direct pregnancy evidence
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
Two-stage 12-week nonpregnant trial
Comparator
Bupropion plus extended-release naltrexone versus placebo
Effect or numbers carried forward

Weighted response 13.6% versus 2.5%

Limitations

Absolute response was modest; naltrexone requires opioid-free status; regimen is not a fixed-dose approved StUD product

Sources, citation controls, and verification state

Linked sources

PMID
33497547
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending