TABLE 4.
Moderators of failure to initiate study medication among patients randomly assigned to extended-release naltrexone (N=283) or buprenorphine-naloxone (N=287)
Treatment-by-Moderator Interactiona |
Treatment Effect |
Estimated Initiation Failure Ratec (%) |
|||||
---|---|---|---|---|---|---|---|
Moderator Variable | F | df | p | Odds Ratiob | 95% CI | Extended-Release Naltrexone | Buprenorphine-Naloxone |
p<0.001 | |||||||
Pain discomfort, moderate or extreme | 13.08 | 1, 559 | <0.001 | ||||
None | 2.18 | 1.04, 4.60 | 16.42 | 8.25 | |||
Moderate or extreme | 23.68 | 8.21, 68.34 | 32.44 | 1.99 | |||
Current probation or parole | 12.20 | 1, 558 | <0.001 | ||||
No | 12.86 | 5.96, 27.76 | 27.04 | 2.80 | |||
Yes | 7.13 | 2, 556 | <0.001 | 1.25 | 0.43, 3.61 | 17.39 | 14.39 |
Prefer to receive buprenorphine-naloxone | 7.13 | 2, 556 | <0.001 | ||||
Disagree | 1.43 | 0.59, 3.44 | 17.50 | 12.94 | |||
Neutral | 9.22 | 3.35, 25.39 | 23.62 | 3.25 | |||
Agree | 55.28 | 7.27, 420.15 | 33.01 | 0.88 | |||
Timing of randomizationd | 13.93 | 1, 559 | <0.001 | ||||
Early | 47.79 | 11.15, 204.89 | 41.30 | 1.45 | |||
Late | 2.26 | 1.15, 4.45 | 17.03 | 8.33 | |||
0.001≤p<0.05 | |||||||
Hispanic ethnicity | 3.98 | 1, 559 | 0.047 | ||||
Not Hispanic | 4.88 | 2.68, 8.89 | 22.95 | 5.75 | |||
Hispanic | 44.49 | 5.49, 360.56 | 37.00 | 1.30 | |||
Current cannabis use | 4.50 | 1, 559 | 0.034 | ||||
No | 4.09 | 2.05, 8.19 | 27.04 | 8.30 | |||
Yes | 18.49 | 5.52, 61.97 | 24.32 | 1.71 | |||
Any past treatment successful | 4.91 | 1, 559 | 0.027 | ||||
No | 4.11 | 2.13, 7.93 | 23.49 | 6.95 | |||
Yes | 25.03 | 5.81, 107.87 | 27.87 | 1.52 | |||
Past methadone or buprenorphine treatment successful | 4.16 | 1, 559 | 0.042 | ||||
No | 4.52 | 2.39, 8.55 | 25.02 | 6.87 | |||
Yes | 40.74 | 5.40, 307.42 | 25.75 | 0.84 | |||
Anxiety or depression levels, moderate or extreme | 4.38 | 1, 559 | 0.037 | ||||
None | 3.15 | 1.35, 7.38 | 21.79 | 8.12 | |||
Moderate or extreme | 10.86 | 4.93, 23.92 | 27.21 | 3.33 | |||
Any friends or family with heroin or other opioid use problems | 4.62 | 1, 554 | 0.032 | ||||
No | 15.88 | 5.33, 47.27 | 30.65 | 2.71 | |||
Yes | 3.89 | 1.97, 7.68 | 21.81 | 6.69 | |||
Prefer to receive extended-release naltrexone: | 5.61 | 2, 556 | 0.004 | ||||
Disagree | 28.59 | 3.65, 224.22 | 30.23 | 1.49 | |||
Neutral | 24.61 | 5.71, 106.01 | 23.57 | 1.24 | |||
Agree | 2.31 | 1.07, 4.98 | 24.54 | 12.35 | |||
Typical discomfort level during past episodes of opioid withdrawal | 7.97 | 1, 557 | 0.005 | ||||
0–7 (0 = none; 1=little discomfort) | 3.08 | 1.48, 6.40 | 19.65 | 7.36 | |||
8–10 (10=almost unbearable) | 19.73 | 6.80, 57.26 | 31.64 | 2.29 |
Logistic regression was conducted, with a p value <0.001 considered significant.
Odds ratios >1.0 favored buprenorphine-naloxone; odds ratios <1.0 favored extended-release naltrexone.
Values are model estimated.
Early randomization occurred within 3 days of the last opioid exposure, illicit or prescribed; late randomization occurred more than 3 days after the last opioid exposure.