Posts Tagged ‘CTN-0027’

Methadone or Buprenorphine Treatment for Opioid Dependence Reduces HIV Risk Behaviors

April 28, 2014

riskResearch over the past 20 years has shown that methadone maintenance (MET) reduces opioid use and is an effective HIV risk reduction intervention as well. Like methadone, treatment with buprenorphine-naloxone (BUP) also appears to reduce HIV risk.

To date, only one study has compared HIV risk in patients receiving MET vs. BUP. This article, currently in-press in JAIDS, reports on a similar comparison of a much larger sample in a secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network (CTN) protocol, “Starting Treatment with Agonist Replacement Therapies (START).”

The Pacific Northwest Node was one of the original nodes involved in the START study, and Dr. Andrew Saxon from the VA Puget Sound Health Care was one of the authors of this ancillary investigation.

START was a randomized, open-label phase 4 study in participants entering opioid agonist treatment programs throughout the country that aimed to compare the effect of BUP and MET on liver function. The Risk Behavior Survey (RBS) was administered to participants, measuring past 30-day HIV risk, at baseline and weeks 12 and 24. Among the 529 patients randomized to MET, 391 (74%) were completers; for BUP, 740 were randomized and 340 completed (46%).

Analysis of the survey results found significant reductions in injecting risk with no differences between groups in mean number of times reporting injecting heroin, speedball, other opiates, and number of injections. There were also no differences between groups in terms of percent who shared needles, did not clean shared needles with bleach, shared cookers, or engaged in front/back loading of syringes.

The percent having multiple sex partners decreased equally in both groups. However, for males on BUP, the sex risk composite increased, while for males on MET, the sex risk decreased, resulting in significant group differences over time. For females, there was a significant reduction in sex risk with no group differences.

Conclusions: Among MET and BUP patients who remained in treatment, HIV injecting risk was equally and markedly reduced, however MET retained more patients. Sex risk was equally and significantly reduced among females in both treatment conditions, but increased for males on BUP and decreased for males on MET. Overall, these findings further support the importance of expanding availability of evidence-based medical treatments for opioid addiction.

Citation: Woody GE, Bruce RD, Korthuis PT, et al. HIV Risk Reduction with Buprenorphine-Naloxone or Methadone: Findings from A Randomized Trial. Journal of Acquired Immune Deficiency Syndromes 2014 (in press).

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Methadone vs. Buprenorphine for Retention: More from the START Study

August 20, 2013

suboxoneThis article, by Yih-Ing Hser, Andrew Saxon (of the Pacific Northwest Node), David Huang, and colleagues, reports on a secondary analysis of data from National Drug Abuse Treatment Clinical Trials Network protocol CTN-0027 (“Starting Treatment with Agonist Replacement Therapies (START)“). It examined patient and medication characteristics associated with retention and continued illicit opioid use in methadone (MET) versus buprenorphine/naloxone (BUP) treatment for opioid dependence.

The differences between the two medications were significant — the treatment completion rate was 74% for MET vs. only 46% for BUP, with the rate for MET participants increasing to 80% when the maximum methadone dose reached or exceeded 60mg/day. With buprenorphine, the completion rate also increased with higher doses, but still only reached 60% at maximum dosage.

Buprenorphine treatment, on the other hand, was associated with significantly lower positive opioid urine test results than methadone in the first 9 weeks of treatment.

The study found 4 clear factors associated with treatment drop-out in this population: 1. Administration of BUP instead of MET; 2. Lower medication dose (<15 for BUP, <60 for MET); 3. The interaction of dose and treatment condition (those with higher BUP dose were 1.04 times more likely to drop out than those with lower MET dose); and 4. Being younger, Hispanic, and using heroin or other substances during treatment.

Conclusions: Provision of methadone appears to be associated with better retention in treatment for opioid dependence than buprenorphine, as does provision of higher doses of both medications. However, provision of buprenorphine is associated with lower continued use of illicit opioids. The high dropout rates at the early phase of buprenorphine treatment suggest the need for early interventions to increase retention for BUP patients.

Citation: Hser Y, Saxon AJ, Huang D, et al. Treatment Retention Among Patients Randomized to Buprenorphine/Naloxone Compared to Methadone in a Multi-Site Trial. Addiction 2013 (in press).

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CTN-0027 Outcomes Paper Published!

August 29, 2012

This paper, currently in press at Drug and Alcohol Dependence and written by Andrew Saxon, Walter Ling, Maureen Hillhouse, and colleagues, reports on the primary outcomes from CTN-0027 (Starting Treatment with Agonist Replacement Therapies (START))Evergreen Treatment Services, a CTP in the Pacific Northwest Node, participated in this study.

Buprenorphine/naloxone (BUP) and methadone (MET) are efficacious treatments for opioid dependence, although concerns about a link between BUP and drug-induced hepatitis have been raised. CTN-0027, Project START, was a randomized controlled trial of 1269 opioid-dependent participants seeking treatment at 8 federally licensed opioid treatment programs and followed up for 32 weeks between May 2006 and August 2012.

Results determined that changes in transaminase levels did not differ by medication condition. Baseline infection with hepatitis C or B was the only significant predictor of moving from low to high transminase levels. MET participants were retained longer than the BUP participants, however the 24-week retention rates for the BUP group in this study were in the range seen in prior studies. In fact, because of its superior safety profile and excellent clinical responses to BUP in previous studies, BUP could be considered a first line treatment agent for opioid dependence, with MET reserved for those who do not respond well to BUP.

Conclusions: This study demonstrated no evidence of liver damage during the initial 6 months of treatment with either BUP or MET, providing further encouragement to physicians to use buprenorphine as an effective treatment option for opioid addiction.

Citation: Saxon AJ, Ling W, Hillhouse M, et al. Buprenorphine/Naloxone and Methadone Effects on Laboratory Indices of Liver Health: A Randomized Trial. Drug and Alcohol Dependence 2012 (in press).

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Presentation on CTN-0029 at APHA 2011

November 21, 2011

apha2011This year’s American Public Health Association annual meeting (Oct. 28 – Nov. 2, 2011 in Washington DC) featured two presentations from the CTN, including one by Pacific Northwest node member Andrew Saxon about CTN-0027 (START):

Community-Based Clinical Trials: Site Variation and Adoption of Innovation by Dennis McCarty and colleagues from the Western States Node examined site differences in five CTN trials and found that variation can affect protocol implementation and influence client outcomes.

Protocol NIDA-CTN-oo27: Starting Treatment with Agonist Replacement Therapies (START) by Walter Ling and Andrew Saxon described the outcomes of that study, which compared liver health in opioid-dependent patients after six months of methadone maintenance or six months of buprenorphine/naloxone.  Worsening of liver health was rare and did not differ by medication condition, but participants in the bup/nal group had poorer treatment retention than those on methadone.

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