Archive for the ‘Protocols’ Category

Opioid Treatment Drugs have Similar Outcomes once Patients Initiate Treatment

November 15, 2017

subvivMedication-assisted treatment is superior to placebo and counseling-only treatment for opioid use disorders, according to a new article by CTN researchers.

This study, CTN-0051, (X:BOT) aimed to estimate the difference in opioid relapse-free survival between Buprenorphine-naloxone (BUP-NX) and extended-release naltrexone (XR-NTX).  It was a 24-week, open-label, randomized controlled, comparative effectiveness trial held in 8 U.S. community-based inpatient services, with outpatient follow-up for participants, all of whom were users or heroin or prescription-type opiates.  Evergreen Treatment Services in the PNW Node was one of 8 participating sites.

While both medications are used to treat OUD, they are pharmacologically and conceptually distinct interventions for preventing opioid relapse, and, until now, a study directly comparing them to each other had not been done.

Half of the participants (283) were randomized to receive XR-NTX (Vivitrol), a monthly injection, with the other half (287) assigned to receive BUP-NX (Suboxone), which came as a film patients placed under their tongues (“sublingual”). Participants were followed for 24 weeks of outpatient treatment, with “relapse”  considered to be 4 consecutive weeks of any non-study opioid use as measured by urine toxicology or self-report, or 7 consecutive days of self-reported use.

As expected, patients randomized to XR-NTX had a substantial induction hurdle: XR-NTX can trigger severe withdrawal in patients if they have not detoxed from opioids first, and detox can be extremely difficult for opioid users (treatment with Suboxone can be started sooner, while the patient is still experiencing some withdrawal). As a result, fewer participants successfully initiated treatment with XR-NTX (72%) than with BUP-NX (94%).

Among all participants who were randomly assigned (“intention-to-treat” population, n=570), 24-week relapse events were greater for XR-NTX (65%) than for BUP-NX (57%). However, most or all of this difference (89%) was due to patients in the XR-NTX group dropping out of detox before receiving the medication.

Of the 474 participants who did successfully begin treatment, however, researchers found that:

  • 24-week relapse events were similar for both XR-NTX and BUP-NX (about half of both groups relapsed). In other words, both medications were equally effective.
  • Self-reported opioid craving was initially less with XR-NTX than with BUP-NX, but by week 24, participants reported similar levels of craving.
  • With the exception of mild-to-moderate XR-NTX injection site reactions, treatment-emergent adverse events, including overdose, did not differ between treatment groups.

Conclusions: In this population of opioid users, it was more difficult to initiate patients to XR-NTX than BUP-NX, and this negatively affected overall relapse. However, once initiated, both medications were equally safe and effective. Future work should focus on facilitating induction to XR-NTX and on improving treatment retention for both medications.

Related:

Citation: Lee JD, et al. Comparative Effectiveness of Extended-Release Naltrexone Versus Buprenorphine-Naloxone for Opioid Relapse Prevention (X:BOT): A Multicentre, Open-Label, Randomised Controlled Trial. The Lancet 2017 (in press).

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Addressing Sexual Issues in Addictions Treatment Workshop – Free CEUs!

January 31, 2012

This 2.5 hour workshop, Addressing Sexual Issues in Addictions Treatment, developed by the CTN Research Utilization Committee (RUC), focuses on the outcomes and clinical utility of National Drug Abuse Treatment Clinical Trials Network protocols CTN-0018 and CTN-0019, which were designed to test gender-specific interventions to reduce HIV sexual risk behavior among clients in drug treatment programs.  Counselors often have a difficult time discussing issues related to sex with their clients.  This workshop aims to provide information and skills that can help begin that dialogue.

The workshop, now available at the CTN Dissemination Library website, features an article from Counselor magazine and brief video from Louise Haynes, MSW, plus two longer video presentations from Pacific Northwest Node researcher Don Calsyn, PhD, and Susan Tross, PhD, the Lead Investigators of the safer sex studies in the CTN.

To qualify for free! continuing education credits (3 each from NAADAC and NBCC), users must read the article, view all three videos, and then pass a 12-item quiz (a passing score is 10/12 correct).  Get started here!


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Teaching Condom Use Skills

November 1, 2010

The latest paper from protocol CTN-0018  by PNW Node researchers Donald Calsyn, Mary Hatch-Maillette, and Suzanne Doyle, as well as other colleagues from the project, was just published in the journal Substance Abuse.

The article, “Teaching Condom Use Skills:  Practice is Superior to Observation,” found that men participating in the study could effectively be taught correct male and female condom use skills using an interactive skills practice exercise, and maintain those skills for up to six months.  Participants only exposed to a demonstration of condom skills, or who received no intervention at all, did not perform as well.

Learn more about the study in the CTN Dissemination Library:  http://ctndisseminationlibrary.org/display/410.htm

Men in Methadone Maintenance versus Psychosocial Outpatient Treatment: Differences in Sexual Risk Behaviors and Intervention Effectiveness from a Multisite HIV Prevention Intervention Trial.

July 29, 2010

This new article in Journal of Addictive Diseases, written by Don Calsyn, Susan Doyle, and Mary Hatch-Maillette of the Alcohol & Drug Abuse Institute at the University of Washington, as well as other colleagues from the National Drug Abuse Treatment Clinical Trials Network (CTN), reports on the effectiveness of the Real Men Are Safe (REMAS) HIV prevention intervention (protocol CTN-0018) as a function of treatment program modality.

REMAS is a five-session sexual risk reduction intervention for men involving didactically delivered informational material, role playing, peer group discussions, and self-assessment motivational exercises (see REMAS manual).

REMAS was associated with significantly larger decreases in unprotected sexual occasions than an HIV education control condition in both methadone maintenance and psychosocial outpatient program participants, however it was especially effective with the latter group.  Potential reasons why are explored in this article, including differences in patient variables, the effects of methadone as a treatment, and greater relevance of the REMAS intervention to patients in outpatient treatment.

Modifications of the REMAS approach may be needed to further enhance effectiveness with methadone maintained patients.

Find the article in the CTN Dissemination Library: http://ctndisseminationlibrary.org/display/512.htm

Article citation: Calsyn DA, Campbell ANC, Crits-Christoph P, Doyle SR, Tross S, Hatch-Maillette MA, Mandler RN.  Men in methadone maintenance versus psychosocial outpatient treatment: Differences in sexual risk behaviors and intervention effectiveness from a multisite HIV prevention intervention trial.  Journal of Addictive Diseases 2010;29(3):370-382. [doi: 10.1080/10550887.2010.489451]

Reducing Sex Under the Influence of Drugs or Alcohol for Patients in Substance Abuse Treatment.

January 7, 2010

In a previous report (Calsyn et al, 2009), the effectiveness of the Real Men Are Safe (REMAS) intervention in reducing the number of occasions of unprotected sex among male patients in drug abuse treatment was demonstrated. A secondary aim of REMAS was to reduce the frequency with which men engage in sex while under the influence (SUI) of drugs or alcohol.

This new article in the journal Addiction, written by Pacific Northwest Node researchers Donald Calsyn, Mary Hatch-Maillette, and Suzanne Doyle, as well as other CTN colleagues, reports the outcomes of that secondary aim, finding that REMAS, an intensive skills-based HIV prevention intervention, was indeed associated with greater reduction in the frequency of SUI among men in substance abuse treatment compared to standard HIV education at the 3-month follow-up.

Read more about this article in the CTN Dissemination Library.

Citation: Calsyn DA, Crits-Christoph P, Hatch-Maillette MA, Doyle SR, Song YS, Coyer S, Pelta S. Reducing sex under the influence of drugs or alcohol for patients in substance abuse treatment. Addiction 2010;105(1):100-108. [doi: 10.1111/j.1360-0443.2009.02812.x]

STAGE-12 Update

November 12, 2009

After months of hard work, the STAGE-12 protocol has met and exceeded their recruitment goal, ending recruitment on September 31st with 471 participants, 21 over the target! The end of the randomization phase came roughly 7 weeks ahead of earlier projections. The PNW Node has two sites participating in the study. Recovery Centers of King County (RCKC) was a part of the first wave, and has now completed all follow-up interviews. As one of only three CTPs to initiate the study, RCKC staff were responsible for helping to fine-tune the protocol as they recruited and tracked participants. Evergreen Manor was part of wave two, and despite the shortened recruitment period, they were able to meet their target of recruiting 40-50 participants! Congratulations to the staff at both of these sites! All follow-ups for this study should be complete by April 12th, 2010.

POATS Study Milestone

September 16, 2009

The Prescription Opiate Addiction Treatment Study (POATS) locked its database on September 8, just 2 months after the last patient information was entered into the InForm electronic data system.

The POATS study (CTN-0030) was carried out at 11 sites, including Providence Behavioral Health Services in the Pacific Northwest Node, and enrolled 653 participants into Phase One of the trial.  Phase Two of the study enrolled 360 participants.  Congratulations to Providence and all POATS participants!

The long-term follow-up study to POATS will follow these participants for another 42 months after the end of the main study.  It is expected to be completed in the summer of 2012.

Tribal Canoe Journey 2009: Paddle to Suquamish

September 1, 2009

tribalOn August 3, 2009, Carmen Rosa of the NIDA Center for the Clinical Trials Network visited the Suquamish Tribe at the Port Madison Indian Reservation in Washington to witness the landing of the canoes, part of Tribal Journeys 2009.    The Suquamish tribe is participating in the Pacific Northwest Node’s protocol CTN-0033-Ot-3, “Methamphetamine: Where Does It Fit in the Bigger Picture of Drug Use of American Indians and Alaska Native Communities and Treatment Seekers?

Tribal Journeys 2009 focused on healing, sobriety, family involvement, team work, and responsibility.  Families from home villages in Washington, Oregon, Alaska, British Columbia, and as far away as Hawaii and New Zealand, started journeys in early July and ended in Suquamish for a week-long celebration, during which they shared cultures, told traditional stories, and passed along tribal teachings to the next generation.

Many thanks to Dennis Donovan, Lisa Rey Thomas, and the rest of the Pacific Northwest Node team for hosting and assisting with this important event!