Table 2.
Studies Performed in People with an Alcohol Use Disorder
| Author, Publication Year, | Study Design | Study Population (N= Initial Population) |
Type, Setting, Aim and Intervention | Duration | Intervention (N= Final Population) |
Outcome | ITT | SBPP |
|---|---|---|---|---|---|---|---|---|
| Studies conducted in peoples with alcohol use disorders | ||||||||
| Busch et al, 201763 | Randomized controlled trial | AUD patients (N=113) |
To compared XR-NTX with O-NTX in treatment attendance prior to discharge | 45 days | O-NTX (N=22) XR-NTX (N=23) |
Both groups had significant reductions in alcohol consumption and high-treatment engagement rates. Both formulations are feasible to initiate prior to discharge for hospital inpatients. |
Yes | No |
| Chokron et al, 201855 | Randomized controlled trial | AUD patients with HIV (N=15) |
To check barriers to initiation and maintenance of XR-NTX | 12 weeks | XR-NTX (N=9) Control (N= 6) |
Two categories of barriers are identified: 1) Those amenable to change: distance and transportation issues, fear of injections, belief that alcohol use does not warrant pharmacotherapy. 2) Those not amenable to change: interaction of XR-NTX with another medication regimen. |
No | No |
| Dermody et al, 201853 | Randomized controlled trial | AUD patients (N=76) |
To identify predictors of daily NTX adherence and to evaluate a mobile health intervention to improve adherence. | 8 weeks | O-NTX + MEMS (N=28) Control (N=30) |
Adherence was higher when daily mobile assessments was completed. Days when individuals drank more than usual were related to lower next-day adherence. Weekend were associated with lower adherence. |
Yes | No |
| Edelman et al, 201957 | Randomized controlled trial | AUD patients with HIV (N=81) |
To evaluate XR-NTX effect on drinking days and improvements in ART adherence or HIV outcomes | 24 weeks | XR-NTX (N=25) Placebo (N=26) |
XR-NTX was associated with fewer heavy drinking days*. XR-NTX was not associated with improvements in ART adherence or HIV outcomes. | Yes | No |
| Farhadian et al, 202049 | Systematic review (1995 to 2019) | AUD patients with HIV (7 studies) | To compare the effects of NTX and XR-NTX. | O-NTX (N=2) XR-NTX (N=5) |
O-NTX and XR-NTX led to reduced alcohol use, improved viral suppression, unchanged ART adherence and has no significant adverse events. Both NTX and XR-NTX have proved to be safety and efficient. |
No | No | |
| Gueorguieva et al, 201324 | Randomized clinical trial | AUD patients (N=1226) |
To compare efficacy of NTX, ACP or PBO alone or with CBT on abstinent and heavy drinking days. | 16 weeks | Intervention group PCO/NTX/ACP/NTX+ACP Control group PCO/NTX/ACP/NTX+ACP CBT (N=1174) |
Excellent adherers had higher PDA and lower PHDD* Either NTX or ACP was associated with lower PHDD than placebo for early non-adherers with CBT*. Younger age, greater drinking severity, dissatisfaction with the medicine and session frequency, adverse events and lack of benefit were related to less favorable medication adherence trajectories. |
Yes | No |
| Henderschot et al, 202054 | Randomized clinical trial | AUD patients (N=76) |
To assess OPRM1 moderation of NTX adherence | 8 weeks | Mobile intervention (N=37) Control (N=39) |
118 G variant/OPRM1 genotype moderated the association of daily adherence with reduced same-day consumption* and craving*. | Yes | No |
| Lohit et al, 201651 | Prospective study | AUD inpatients. (N =102) |
To examine the factors influencing the pattern and extent of anti-craving medication adherence and drinking outcomes at discharge. | 18 months | 7% - NTX 74% - ACP 7% - Disulfiram (N =79) |
A reduction in adherence to ACP and NTX was associated with decrease in days to alcohol abstinence and increase in relapse rate compared to adherent group*. Barriers to adherence included younger age, self-decision, emotional factors, and adverse effects. |
Yes | Yes |
| Malone et al, 201950 | Randomized controlled trial | AUD patients (N =345) |
To examine the effectiveness of XR-NTX and O-NTX | 20–24 weeks | O-NTX (N=120) XR-NTX (N=117) |
XR-NTX in a primary care setting is potentially more efficacious, feasible, and cost-effective than O-NTX*. | Yes | No |
| Pettinati et al, 201156 | Randomized controlled trial | AUD patients (N = 624) |
To examined the efficacy of XR-NTX | 24 weeks | XR-NTX (N=50) PBO (N = 47) |
XR-NTX was effective in high severity alcohol dependence for both reduction in heavy drinking and maintenance of abstinence, with implications for the role of adherence pharmacotherapy. | Yes | No |
| Stout et al, 201459 | Randomized clinical trial | AUD patients (N=1216) |
To evaluate variables related to treatment discontinuation. | 16 weeks | Adherence (N= 559) Discontinuation (N=450) |
A patient’s decision to stop taking medications during alcohol treatment appears to take place during a weeks-long process of disengagement from treatment. Patients who discontinue medications early in treatment or without medical consultation appear to drink more frequently and more heavily. | Yes | No |
| Stoner et al, 201552 | Randomized controlled trial | AUD patients (N = 76) |
To evaluate whether a mobile health intervention could improve naltrexone adherence. | 8 weeks | NTX (N=39) NTX + MEMS (N=37) |
Intervention group sustained adequate adherence significantly longer than those in the control group* | Yes | No |
| Vuoristo et al, 201325 | Pre-post intervention | AUD patients (N=315) |
To assess drinking pattern response to NTX +CBT | 16 weeks | Pre-intervention (NTX+CBT) Post-intervention (N=165) |
Medication non-adherence is a major barrier to naltrexone’s effectiveness in a real-life treatment setting. Patients with more severe alcohol problems may need more intensive treatment for achieving better treatment outcome in real-word treatment settings. |
Yes | Yes |
| Walker et al, 201948 | Retrospective chart review | AUD patients (N=715) |
To identify differences in adherence across medications | 6 months | Adherence of 80% 11.9% Disulfiram 19.4% ACP 22.7% O-NTX 24.4% XR-NTX |
Overall adherence to medication-assisted treatment for alcohol use disorder is low across all medications. Disulfiram had lower adherence than both oral and extended-release injectable naltrexone.* |
No | No |
| Witkiewitzet al, 201826 | Randomized controlled trial | AUD patients (N=1226) |
To evaluate clinical outcomes in AUD patients with opioids misused | 68 weeks | Medication management (ACP, NTX, Placebo) Behavioral + Medication management |
Opioid misuse in AUD showed lower rates of medication adherence * Medication adherence partially mediated the association between opioid misuse, cannabis use, other drug use, and treatment outcomes. For patients with opioid misuse who are in treatment for AUD, XR-NTX could enhance treatment adherence. |
Yes | No |
| Studies conducted in people with comorbid alcohols and opiods use disorders | ||||||||
| Cousins et al, 201735 | Non randomized and controlled. Intervention study. | Patients with both AUD and OUD. (N= 1908) |
Assess adherence between the first and fifth year of treatment. | 5 years | Check adherence to XR- NTX in 2010 and 2015. (N= 1908) |
XR-NTX initiation doses increased by 59% by the fifth year of the demonstration project compared to Year 1.* The number of subsequent doses increased by 89% from Year 1 to Year 5.* | No | Yes |
| Springer et al, 201458 |
Randomized controlled trial | AUD and OUD with HIV (N=401) |
To assess acceptability and retention on XR-NTX among persons living with HIV disease under criminal justice setting | 1 month | (N=167) | CJS based XR-NTX programs are highly acceptable among PLH, however retention on XR-NTX after release is negatively impacted by relapse to cocaine use. | Yes | No |
Note: *Statistical significative.
Abbreviations: NTX, naltrexone; O-NTX, oral naltrexone; XR-NTX, extended-release naltrexone; ACP, acamprosate; PCB, placebo; CBT, cognitive behavioural therapy; VS, ventral striatum; MEMS, Medication Event Monitoring System; PDA, percent days abstinent; PHDD, percent heavy drinking days; PLH, people living with HVI; CJS, criminal justice system; AUD, alcohol use disorder; OUD, opioid use disorder; ITT, intention-to-treat analysis; SBPP, studies based on patient preferences.