Phase 2
Completed N=11
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene
Source: ClinicalTrials.gov NCT03278886 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Aug 2020
Primary outcomePrimary: Medication Tolerability Measured Via a 0-100 Visual Analog Scale — 90.7; NA score on a scale
Summary
This study is a randomized controlled trial (RCT) to assess the feasibility, tolerability, and safety of using opioid receptor antagonists (naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Tolerability Measured Via a 0-100 Visual Analog Scale |
90.7; NA | — |
| SECONDARY Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks |
5.5; -6.83 | — |
| SECONDARY Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period |
1; 1; 1; 2 | — |
| SECONDARY Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks |
87.5; 0 | — |
| SECONDARY Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence |
1; 0 | — |
| SECONDARY Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question |
1.5; 4.5; 1.3; 1.5; 0.9; 1.5 | — |
| SECONDARY Medication Satisfaction Defined as a Score From 0-100 Measured Via the Treatment Satisfaction Questionnaire for Medication (TSQM), With Higher Scores Corresponding to Higher Treatment Satisfaction. |
47.3; 3.6; 47.3; 3.6 | — |
| SECONDARY Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- HIV-positive
- Chronic pain (present ≥3 mo) of moderate to severe intensity
- Heavy drinking past year (Based on NIAAA criteria: > 14 standard drinks per week/ > 4 drinks in a day for men; > 7 drinks in the past week/ > 3 drinks in a day for women)
- If female, negative pregnancy test and willing to use adequate birth control
- Provision of contact information for 2 contacts to assist with follow-up
- Stable address within 100 kilometers of St. Petersburg
- Possession of a telephone (home or cell)
- Able and willing to comply with all study protocols and procedures
Exclusion Criteria
- Not fluent in Russian
- Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment
- Known active TB or current febrile illness
- Breastfeeding
- Uncontrolled psychiatric illness (such as active psychosis) (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ED or hospital)
- History of hypersensitivity to naltrexone, nalmefene, or naloxone
- Current use (past week) of illicit or prescribed opiates as documented by either self-report or positive urine drug test
- Unwilling to abstain from opiates during the treatment period
- Current use of neuroleptics
- History of seizure disorder
- Known liver failure
- ALT/AST levels >5x normal
- History of Raynaud's Disease
- Planned surgeries in the next three months
- Enrolled in another HIV and/or substance use medication intervention study
- Taking naltrexone in the past 30 days
- Taking nalmefene in the past 30 days
Data sourced from ClinicalTrials.gov (NCT03278886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.