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Clinical Trials Network (CTN) News Briefs

The ATTC Network Coordinating Office is please to share brief summaries of some of the latest research findings available in the Clinical Trials Network (CTN) Library.

The CTN Dissemination Library is a digital repository of resources created by and about NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN). It provides CTN members and the public with a single point of access to research findings and other materials that are approved for dissemination throughout the CTN and to the larger community of providers, researchers and policy-makers.

CTN Study Finds No Evidence of Liver Damage from Buprenorphine/Naloxone

Buprenorphine/naloxone and methadone are effective treatments for opioid dependence, although concerns about a link between buprenorphine and drug-induced hepatitis have been raised.

“ Starting Treatment with Agonist Replacement Therapies” (Project START), was a National Drug Abuse Treatment Clinical Trials Network-funded randomized controlled trial of 1269 opioid-dependent participants seeking treatment at 8 federally licensed opioid treatment programs, with follow-up for 32 weeks.

Analyses of liver tests administered regularly through the follow-up period revealed that changes in transaminase levels, a primary indicator of liver disease, did not differ by medication condition. Baseline infection with hepatitis C or B was the only significant predictor of moving from low to high transaminase levels.

Methadone participants were retained longer than the buprenorphine/naloxone participants, however the 24-week retention rates for the buprenorphine/naloxone group in this study were in the range seen in prior studies.  In fact, because of its superior safety profile and excellent clinical responses, the Project START researchers suggest that buprenorphine/naloxone could be considered a first-line treatment agent for opioid dependence, with methadone reserved for those who do not respond well to buprenorphine/naloxone.

Conclusions: This study demonstrated no evidence of liver damage during the initial 6 weeks of treatment for opioid dependence with either buprenorphine/naloxone or methadone, providing further encouragement to physicians to use buprenorphine as an effective treatment option for opioid addiction.  Read more about Project START in the CTN Library.

Raters Unaffiliated with Tested Treatment May Have Most Objective Feedback

This examination of data from the National Drug Abuse Treatment Clinical Trials Network-funded evaluation of the “Stimulant Abuser Groups to Engage in 12-Step” (STAGE-12) intervention, a manualized 12-Step facilitation (TSF) group and individual treatment, investigated the correspondence among four types of raters on adherence to the STAGE-12 protocol.

The four rater groups compared consisted of the study therapists, their supervisors, study-related (“TSF expert”) raters, and non-project-related (“external”) raters.

In research, adherence is typically rated by highly trained experts in the intervention being studied.  Compared to independent, expert raters, therapists and their supervisors tend to rate therapist adherence higher, suggesting a favorability bias.  But what about expert raters who have a stake in the intervention’s success compared to raters with no stake in the outcomes at all (“external” raters)?

Results of this comparison found that those non-expert “external” raters rated Mean Adherence (the mean of all the adherence items) and global performance the most critically of the rater groups.  External raters also demonstrated the highest degree of reliability with the designated expert. Different from previous research, therapists in this study were harder on their adherence that expected, rated their adherence lower, on average, than the supervisors and TSF expert raters. However, therapist ratings also had the poorest reliability.

Conclusions:  Findings highlight the challenge in developing practical but effective methods of fidelity monitoring for evidence-based practice in clinical settings. While funding and licensing agencies increasingly call for use of evidence-based treatments, community-based organizations implementing them will seek the simplest, most reliable and cost-effective ways of monitoring their delivery.  These results suggest that there may be a role for on-site therapists or supervisors rating adherence, as long as adequate training on rating procedures is provided, but that raters unaffiliated with the treatment being tested may provide the most objective scores. Read more about this study in the CTN Library.

Clinicians' Intentions to Use Computer-Assisted Treatment

A survey was conducted with 96 clinicians participating in a larger NIDA CTN study. Overall, the clinicians reported that their clinic was only slightly likely to use web-delivered interventions to treat substance use disorders. The researcher found that clinicians’ attitudes (“web-delivered interventions are good”) and social norms (“people who are important to me think that web-delivered interventions should be used”) were related to intentions to use technology. These results are interesting because other research has also found that social norms are related to addiction treatment program adoption of new therapies, including the use of medication assisted treatment. Creating an organizational culture that believes that technology use in treatment is good and reflects what should be done, may be important to successfully transitioning technology into standard care. The NIDA CTN conducted a large randomized study of a computer-based therapeutic intervention, based on the Community Reinforcement Approach, and the results will be forthcoming in the near future. You can read more about clinicians’ intentions to use computer-assisted treatment at the CTN Library.

Technology Articles from the NIDA CTN: Are Patients and Clinicians Ready to Use Technology?

Use of Technology by Patients in Treatment for Substance Use Disorders. Before considering whether to integrate technology into routine clinical care, it is important to consider the type of technology that patients are using. A survey was conducted with 266 patients in addiction treatment at 8 urban clinics. The average age of the survey respondents was 41 years old and 57% of the respondents had an annual income less than $15,000. This survey found that:

  • 85% of patients had a mobile phone
  • 79% of patients were able to text message
  • 39% of patients used a computer at least weekly
  • 44% of patients used the internet at least weekly
  • 45% of patients used email at least weekly

The percentage of patients in addiction treatment that have a mobile phone is comparable to the national average (88%), however many patients (60%) reported having a pay-as-you-go plan and 63% reported having their phone number change at least once in the past year. Patients in treatment had significantly lower, on average, regular use of the internet or computers compared to the national average (78%). Read more about this study at the CTN Library.




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