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Research for Innovative Care

Clinical Policy: Management of Patients on Controlled Substances under Treatment Agreement

Purpose

This policy establishes standardized procedures for the management of patients who sign a Patient Treatment Agreement for the use of controlled substances in the treatment of chronic pain, addiction, and/or cannabis therapy. The goal is to ensure patient safety, promote compliance, and reduce risks associated with controlled substance prescribing.

Scope

This policy applies to all providers, clinical staff, and patients enrolled in the clinic’s chronic pain and addiction treatment program. It covers:

  • Patients treated with full agonist opioids.
  • Patients treated with the partial agonist- buprenorphine.
  • Patients treated with cannabis under clinic supervision.

Prohibited Substances

Patients are obligated to avoid the use of the following substances unless explicitly prescribed and approved by this clinic:

  • DEA Schedule II–IV controlled substances including:
    • Opioids (not prescribed by the clinic)
    • Cannabis (not prescribed or certified by the clinic)
    • Benzodiazepines
    • Z-drugs (e.g., zolpidem, eszopiclone)
    • Barbiturates
    • Amphetamines
    • Cocaine
  • Other prohibited substances:
    • Tianeptine
    • Kratom, mitragynine, 7-hydroxymitragynine
    • Phenibut- B-phenyl-y-aminobutyric acid
    • O-desmethyltramadol

Phases of Care

1. Maintenance Phase

  • Reserved for patients in stable condition with full compliance to the treatment agreement.
  • Patients are scheduled on a monthly recall basis (approximately every 30 days, ±7 days for scheduling needs).

2. Stabilization Phase

  • Patients who violate the treatment agreement will be transitioned into the stabilization phase.
  • Patients are required to attend weekly visits (approximately every 7 days, ±7 days for scheduling needs).
  • Patients must demonstrate two consecutive fully compliant visits to transition back to the maintenance phase.

Violations of the Treatment Agreement

The following are considered violations:

  1. Abnormal drug testing results (urine, saliva, hair, or nail testing).
  2. PDMP violations, including obtaining prescriptions for prohibited substances from outside providers without prior approval.
  3. Use of any prohibited drugs as listed above.
  4. Failure to attend scheduled appointments, resulting in a lapse of greater than 2 months without a clinic visit.

Management of Violations

  1. Patients who violate the treatment agreement will:
    • Be transitioned from maintenance phase to stabilization phase.
    • Be required to attend weekly visits until compliant for two consecutive visits.
  2. Patients not seen in the clinic for greater than 2 months will automatically be placed in the stabilization phase and required to demonstrate two consecutive compliant weekly visits before returning to maintenance phase.
  3. The medical provider may exercise clinical judgment to:
    • Adjust medication regimen (change drug or dosage).
    • Discontinue controlled substances.
    • Refer the patient to a higher level of care, including inpatient drug and alcohol rehabilitation.

Recall Visit Standards

  • Weekly recall = approximately every 7 days (±7 days for scheduling flexibility).
  • Monthly recall = approximately every 30 days (±7 days for scheduling flexibility).

Compliance and Monitoring

  • At every visit, the provider will:
    • Review PDMP records.
    • Assess compliance with the treatment agreement.
    • Determine whether the patient remains in stabilization or maintenance phase.
  • Patients in either phase remain subject to random drug testing.

Policy Statement

This policy supports patient safety by balancing access to controlled substances with strict oversight. Patients who fail to meet treatment expectations will be closely monitored, stabilized, and, if necessary, referred for more intensive care. Compliance with the treatment agreement is mandatory for continued participation in the program.

Clinical Workflow: Patient Management under Treatment Agreement

Entry Point

  • Patient signs Treatment Agreement
  • Assigned to Maintenance Phase (monthly recall) if compliant at baseline

Maintenance Phase (Monthly Recall ±7 days)

  • Stable patients seen every 30 days.
  • Monitoring:
    • PDMP check
    • Random/targeted drug testing
    • Review adherence to agreement

Violation Detected

Violations include:

  • Abnormal drug testing result
  • PDMP violation (outside prescriptions without approval)
  • Use of prohibited drugs (opioids not prescribed by clinic, benzodiazepines, Z-drugs, barbiturates, amphetamines, cocaine, cannabis not approved by clinic, tianeptine, kratom, mitragynine, 7-hydroxymitragynine, O-desmethyltramadol)
  • Missed appointments with >2 months lapse in care

Transition to Stabilization Phase

  • Patient moved from Maintenance → Stabilization Phase
  • Weekly visits (±7 days) required
  • Provider may:
    • Adjust medication
    • Lower or discontinue controlled substances
    • Refer to higher level of care (e.g., inpatient rehab)

Stabilization Phase (Weekly Recall ±7 days)

  • Patients must attend two consecutive fully compliant visits.
  • Compliance = clean/expected drug testing + no PDMP violations + attendance within recall window

Transition Back to Maintenance Phase

  • After two consecutive compliant visits, patient returns to:
    • Monthly recall (±7 days)
    • Ongoing monitoring

Summary Flow (Text Version)

  1. Maintenance Phase (monthly recall)
    ↓
  2. Violation detected (drug test, PDMP, prohibited drug use, lapse >2 months)
    ↓
  3. Stabilization Phase (weekly recall)
    ↓
  4. Two compliant visits
    ↓
  5. Return to Maintenance Phase

References

1) Informed consent: tolerance, physical dependence, opioid-induced hyperalgesia (OIH)

  • CDC 2022 Opioid Guideline (MMWR) — explains risks of long-term opioids, including tolerance, physical dependence, OUD, and overdose; provides clinician–patient communication and monitoring recommendations. CDC+1
  • Review of OIH (Pain Physician / Lancet commentary) — summarizes clinical and mechanistic evidence that prolonged opioid exposure can paradoxically increase pain sensitivity (hyperalgesia). Pain Physician+1

2) Avoiding dangerous combinations (opioids + benzodiazepines / other CNS depressants)

  • FDA Drug Safety Communication & boxed-warning update — strong warnings about serious breathing problems and death when opioids are combined with benzodiazepines or other CNS depressants. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2
  • NIDA clinical summary — concurrent use increases life-threatening overdose risk. National Institute on Drug Abuse
  • BMJ claims study (Sun et al., 2017) and JAMA Network Open cohort (2018) — concomitant opioid–benzodiazepine use is associated with markedly higher overdose risk. BMJ+1

3) PDMP checks at every visit / regularly

  • CDC PDMP guidance (2024 page reflecting 2022 Guideline) — check PDMP when initiating and every 3 months or more frequently when continuing opioids; ideally before every opioid Rx. This supports reviewing PDMP at each visit in a high-risk clinic. CDC
  • VA/DoD & VA policy pages — align with CDC and operationalize PDMP querying within federal systems. Veterans Affairs+1

4) Toxicology monitoring (urine, saliva/oral fluid, hair, and nail when indicated)

  • SAMHSA technical/operational guidance — federal urine and oral-fluid Mandatory Guidelines and collection manuals; supports specimen validity, confirmation testing, and clinical appropriateness of multiple matrices. SAMHSA+2SAMHSA+2
  • Clinical Drug Testing in Primary Care (SAMHSA TAP 32) — clinical implementation guide for drug testing (test before/periodically during therapy; risk-based frequency). claritylabs.com
  • Keratinized matrices (hair/nail) — peer-reviewed reviews — hair and nails provide longer detection windows and are useful adjuncts to urine/oral fluid in treatment monitoring. SpringerLink+1

5) Phase-based care & visit frequency (weekly “stabilization” vs monthly “maintenance”)

  • CDC 2022 Guideline — calls for closer follow-up in higher-risk situations (e.g., aberrant behaviors, dose changes) and more frequent monitoring than annual UDT/3-month PDMP when risk is elevated—supporting your weekly visit stabilization policy and monthly maintenance for stable patients. CDC+1
  • VA/DoD 2022 Chronic Pain Opioid Guideline — recommends risk-stratified monitoring, reassessment after violations or safety concerns, and considering taper or higher levels of care—consistent with moving patients to a stabilization pathway and escalating care if needed. Health Quality VA+1

6) Buprenorphine, full agonist opioids, and safety with sedatives

  • SAMHSA Buprenorphine Quick Start Guide — patient education includes heightened overdose risk when benzodiazepines or alcohol are used with buprenorphine and warns against abrupt discontinuation. SAMHSA
  • FDA safety communication for MOUD — counsel patients in MAT about risks of concomitant CNS depressants while recognizing the harm of restricting MOUD access; supports your approach of monitoring and counseling rather than blanket denial. U.S. Food and Drug Administration
  • NIDA analysis/news release — expanding buprenorphine access did not increase overdose deaths, underscoring its favorable safety profile compared with full agonists when used properly. National Institute on Drug Abuse

7) Cannabis & controlled substances obtained outside the clinic

  • CDC 2022 Guideline — emphasizes avoiding concurrent sedatives/CNS depressants and coordinating care across prescribers; supports your requirement for prior approval and for clinic-managed cannabinoids. CDC
    (Note: Evidence on opioid–cannabis co-use is mixed; your policy is a safety/coordination standard consistent with guideline principles of minimizing risky combinations and consolidating controlled-substance management.)

8) Prohibited non-prescribed/“gas-station” products: kratom (mitragynine/7-OH), tianeptine, phenibut, O-desmethyltramadol

  • FDA on Kratom — mitragynine and 7-hydroxymitragynine have opioid-like effects and are linked to dependence, respiratory depression, and deaths; FDA repeatedly warns against use. U.S. Food and Drug Administration
  • Kratom adulteration with O-desmethyltramadol (“Krypton”) — case series linking product to fatal poisonings; highlights adulteration risks. Oxford Academic
  • FDA warnings on Tianeptine — repeated advisories and recalls due to serious risks; widely sold as “gas-station heroin.” U.S. Food and Drug Administration
  • Phenibut — FDA states products declaring phenibut as a dietary ingredient are misbranded; reports of severe toxicity and deaths underscore abuse potential. U.S. Food and Drug Administration+2CSPI+2

9) Handling acute pain prescriptions from outside prescribers

  • CDC 2022 Guideline — stresses care coordination, reassessing during subacute periods to prevent unintended long-term therapy, and reviewing PDMP when new opioids are initiated; supports your prior-approval step before filling external acute opioid Rx. CDC+1

Quick source list (for policy appendix)

  1. CDC. Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR 71(RR-3):1–95. CDC+1
  2. CDC. PDMPs — When to check. (2024). CDC
  3. FDA. Serious risks when combining opioids with benzodiazepines. (2016 update; labeling change). U.S. Food and Drug Administration+1
  4. Sun EC et al. Opioid + benzodiazepine overdose risk. BMJ 2017. BMJ
  5. Hernandez I et al. Concurrent opioid–benzodiazepine use & overdose. JAMA Netw Open 2018. JAMA Network
  6. Lee M et al. Opioid-induced hyperalgesia review. Pain Physician 2011; Lancet commentary. Pain Physician+1
  7. SAMHSA. Clinical Drug Testing in Primary Care (TAP 32); Urine & Oral Fluid Mandatory Guidelines/Manuals (2023–2024). claritylabs.com+2SAMHSA+2
  8. Cappelle D et al. Nail analysis for drugs of abuse (review). Forensic Toxicol 2015. SpringerLink
  9. VA/DoD. Use of Opioids in the Management of Chronic Pain (2022); VA PMOP pages. Health Quality VA+2Health Quality VA+2
  10. SAMHSA. Buprenorphine Quick Start Guide; FDA MAT safety communication. SAMHSA+1
  11. NIDA. Buprenorphine & overdose trends; Opioids + benzodiazepines. National Institute on Drug Abuse+1
  12. FDA. Kratom risks; Tianeptine warnings/recalls; Phenibut actions. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2
  13. Kronstrand R et al. Krypton (kratom + O-desmethyltramadol) fatal poisonings. J Anal Toxicol 2011. Oxford Academic

How these support your specific policies

  • Monthly maintenance vs weekly stabilization after violations aligns with guideline principles for risk-stratified monitoring and more frequent follow-up when safety concerns arise (aberrant tests/PDMP), while allowing return to less intensive follow-up after documented compliance. CDC+1
  • Universal PDMP checks & toxicology (urine ± oral fluid; hair/nail to extend detection window) are specifically recommended or supported by CDC and SAMHSA, with keratinized matrices documented in forensic/clinical literature. SpringerLink+3CDC+3claritylabs.com+3
  • Prohibitions on unsupervised opioids/benzos/Z-drugs/barbiturates/amphetamines/cocaine are grounded in overdose risk with sedative combinations and stimulant misuse; kratom/tianeptine/phenibut/O-desmethyltramadol are supported by FDA warnings and peer-reviewed reports of severe toxicity and deaths. 

Patient Treatment Agreement

Management of Controlled Substance Medication in Chronic Pain and Addiction Treatment Clinic

Purpose

The intent of this agreement is to promote safe and effective management of controlled substances in the treatment of chronic pain and addiction, while minimizing the risks of misuse, dependence, diversion, and other adverse outcomes.

By signing this agreement, the patient acknowledges understanding of the risks and responsibilities associated with controlled substance therapy and agrees to comply with the clinic’s policies to ensure safety and success of treatment.

Informed Consent and Risks

I understand and acknowledge that:

  1. Opioid Tolerance and Dependence – Prolonged use of opioids may result in tolerance (reduced effectiveness requiring higher doses) and physical dependence.
  2. Opioid-Induced Hyperalgesia – Long-term opioid use can cause increased sensitivity to pain (hyperalgesia).
  3. Addiction Risk – Opioids, benzodiazepines, stimulants, and other controlled substances carry a high risk of misuse and addiction.
  4. Overdose Risk – Combining opioids with other sedating medications (benzodiazepines, alcohol, Z-drugs, etc.) greatly increases the risk of overdose and death.

Phases of Care

  1. Maintenance Phase
    • Patients who demonstrate stability and compliance will be managed in the maintenance phase.
    • Maintenance patients will be seen on a monthly recall basis.
  2. Stabilization Phase
    • Patients who violate the treatment agreement will be placed in the stabilization phase.
    • Stabilization patients must attend weekly visits.
    • Patients must complete two consecutive visits in full compliance before returning to the maintenance phase.

Prescription Monitoring and Approval

  1. Acute Pain Prescriptions
    • Patients prescribed controlled substances (DEA Schedule II–IV) for acute pain must call the clinic and receive prior approval before filling the prescription.
  2. Prohibited Medications Without Prior Authorization
    Patients may not obtain prescriptions from other providers for the following medications without prior approval from the clinic:
    • Opioids (not prescribed by this clinic)
    • Benzodiazepines
    • Z-drugs (e.g., zolpidem, eszopiclone)
    • Barbiturates
    • Amphetamines or other stimulants
    • Cocaine
    • Cannabis (unless certified and managed by this clinic)

Other prohibited substances include:

  • Tianeptine
  • Kratom, mitragynine, and 7-hydroxymitragynine
  • Phenibut
  • O-desmethyltramadol

Monitoring and Compliance

  1. Drug Testing
    • I will be subject to urine, saliva, hair, and nail testing to verify compliance.
  2. Prescription Drug Monitoring Program (PDMP)
    • The clinic will review the PDMP at each visit to confirm that I have not received unauthorized prescriptions from other providers.
  3. Violation of Agreement
    • Failure to comply with the above conditions may result in:
      • Transition to the stabilization phase of care (weekly visits).
      • Reduction or discontinuation of controlled substance therapy.
      • Possible referral for higher-level addiction treatment.

Acknowledgment

By signing below, I confirm that I:

  • Understand the risks of controlled substance therapy.
  • Agree to abide by the clinic’s treatment agreement.
  • Authorize the clinic to conduct testing and PDMP checks as described.
  • Understand that violation of this agreement may result in changes to my care plan, including discontinuation of controlled substances.

Patient Name: __________________________
Patient Signature: ______________________ Date: ________

Provider Name: _________________________
Provider Signature: _____________________ Date: ________

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