Category: RCT

Double trouble: opioids and pain among people with substance use disorders


Against the use of opioids for chronic non-cancer pain to people who have active substance use disorders advises the third recommendation in the new opioid therapy guidelines (May 8th, 2017).

However, this “strong” recommendation is based on low quality of evidence from studies that rarely involve people with active substance use disorders (SUD).


Here, we first highlight the main caveats in the research of pain treatment among people with SUDs, why this has been the case and then we offer potential solutions for overcoming the obstacles in clinical research and policy.

Most clinical trials of pain medications exclude people with SUDs. Denying treatment of pain with opioids to people with active SUDs in the absence of evidence, based on a presumed potential for “more” addiction and documented adverse side effects (overdose), is cautious. However, it is also likely influenced by stereotypes and stigma towards people who use drugs and it further discriminates people with SUDs. Instead of stigma, the society should seek better ways of increasing rapid access to evidence-based opioid agonist therapy for prescription opioid use disorders (see Ahamad & Socias, 2016).

Moreover, this approach can lead to unanticipated consequences, such as seeking illicit drugs (see Voon et al, 2015). It is clear that we need more research to better understand pain treatment among people with SUDs and to give better recommendations to clinicians. But what kind of further research? Firstly, we need clinical trials that specifically include people with SUDs, such as people receiving opioid agonist treatment (Ti et al., 2015). If trialists refuse to include people with pain and concurrent SUDs into pain trials, presumably because of their high-risk for more SUDs, this obstacle can be overcome by including a standardized measure of pain, like the VAS, into every pharmacotherapy trial of SUD treatment.

Which pain patient treated with opioids will develop opioid use disorder?

Secondly, we still don’t know which pain patient treated with opioids will develop opioid use disorder (OUD). Despite the typical occurrence of OUDs among approximately 5.5% of the study populations in pain trials, there is no evidence for a reliable predictor of who will develop OUD. We need to find valid risk indicators.

Finally, the current opioid overdose crisis in many countries is primarily driven by not-as-prescribed-use of fentanyl – an anesthetic used to tranquilize elephants. What if people with opioid use disorders self-medicated their pain with fentanyl (see Voon et al., 2015)? What if their pain, both emotional and physical, was as big as elephants and we had nothing for them? What we offer to them is suspicion, exclusion, denial and mistrust. We should offer compassion and fairness.

Cited sources:

  • Busse, J. W., et al. (2017). “Guideline for opioid therapy and chronic noncancer pain.” Canadian Medical Association Journal 189(18): E659-E666.
  • Socias, M. E. and K. Ahamad (2016). “An urgent call to increase access to evidence-based opioid agonist therapy for prescription opioid use disorders.” Canadian Medical Association Journal 188(17/18): 1208.
  • Ti, L., et al. (2015). “Denial of pain medication by health care providers predicts in-hospital illicit drug use among individuals who use illicit drugs.” Pain Research & Management 20(2): 84-88.
  • Voon, P., et al. (2015). “Pain among high-risk patients on methadone maintenance treatment.” The journal of pain 16(9): 887-894.

Two birds with one stone: physicians training in research

Combined training in addiction medicine and research is feasible and acceptable for physicians – a new study shows; however, there are important barriers to overcome and improved understanding of the experience of addiction physicians in the clinician-scientist track is required.

Addiction care is usually provided by unskilled lay-persons in most countries. The resulting care is inadequate, effective treatments are overlooked and millions of people suffer despite recent discovery of new treatments for substance use disorders. In rare instances when addiction care is provided by medical professionals, they are not adequately trained in caring for people with substance use disorders and, therefore, feel unprepared to provide such care.  Physician scientists are the bridge between science and practice. Despite large evidence-base upon which to base clinical practice, most health systems have not combined training of healthcare providers in addiction medicine and research. 
In recent years, new programmes have emerged to train the comprehensive addiction medicine professionals internationally.

We undertook a qualitative study to assess the experiences of 26 physicians who completed such a training programme in Vancouver, Canada. They included psychiatrists, internal medicine and family medicine physicians, faculty, mentors, medical students and residents. All received both addiction medicine and research training. Drawing on Kirkpatrick’s model of evaluating training programmes, we analysed the interviews thematically using qualitative data analysis software. We identified five themes relating to learning experience that were influential: (i) attitude, (ii) knowledge, (iii) skill, (iv) behaviour and (v) patient outcome. The presence of a supportive learning environment, flexibility in time lines, highly structured rotations, and clear guidance regarding development of research products facilitated clinician-scientist training.  Competing priorities, to include clinical and family responsibilities, hindered training.

Read more here:
Klimas, J., McNeil, R., Ahamad, K., Mead, A., Rieb, L., Cullen, W., Wood, E., Small, W. (2017) Two birds with one stone: Experiences of Combining Clinical and Research Training in Addiction Medicine. BMC Medical Education, 17:22

Publication Impact of Addiction Clinician-Scientist Fellowship

This study evaluated the impact of an addiction medicine research fellowship. As such, the evaluation here has the potential to radically change addiction medicine clinician-researcher training. 
Clinician-scientists serve to bridge the gap between addiction research and clinical practice but cultivating these clinician-scientists who are able to publish clinical research remains a challenge.
Objective. To determine if a one-year structured fellowship program for addiction medicine physicians would lead to increased rates of publication.
Design. A non-randomized controlled trial.
Setting. A Canadian academic hospital.
Participants. The study sample was drawn from those physicians who applied to a part-time, one-year addiction research immersion training program. Of the 8 top-ranked individuals from the 11 applicants, 4 were selected to participate in the training program and another 4 were designated to serve as a comparison group. Participants were compensated for their time.
Intervention. The addiction research immersion training program consisted of 3 half-days per week of addiction research training, 2 half-days per week of longitudinal research methods training, and 3 half-days per week of mentored publication and grant development. The control group continued in their usual clinical practice.
Main outcome measure. Number of first-author publications at the end of the one-your fellowship.
At the end of the one-year fellowship, the 4 fellows published 7 papers and the controls published 1 paper; however, this difference was not statistically significant.

These preliminary results suggest that a structured clinical-research training program could lead to an increased rate of publications.

How can we do better job in studying Topiramate?

Topiramate prevents seizures in people with epilepsy. Previously, we looked at all studies to see whether Topiramate can help treat cocaine addiction, reduce cocaine use and prolong treatment retention.
No current evidence supported the clinical use of Topiramate for the treatment of cocaine dependence.
Some of these studies were not blinded. This means that the participants knew whether they got the actual Topiramate or a flat placebo. Too many people dropped out of these studies. They did not measure things in the same way. For instance, not a single study measured craving in the same way. If things from several studies aren’t measured in the same way, we cannot put them together to answer the question whether Topiramate works. Finally, the studies excluded people who also had other drug use disorders. Most people have multiple disorders.
One study was different than all others. It was Dutch. Not only did the participants use less cocaine but they also received less Topiramate and their dose was set over a shorter time than in the American studies.
All of these cues make Topiramate very interesting to study even more, especially if it’s paired with a structured support, such as contingency management. Contingency management helps people curb cocaine addiction by rewarding healthy habits.
There is no drug for cocaine use disorder.  In the past, researchers have studied whether drugs for depression, epilepsy or seizures could treat cocaine addiction.
Until we do better job as researchers, we won’t know whether Topiramate works for cocaine use disorder.
Reference: Klimas, J., Wood, E., Werb, D. How Can We Investigate the Role of Topiramate in the Treatment of Cocaine Use Disorder More Thoroughly? Addiction, 2016, In Press: 

What do persons on methadone in primary care think about alcohol screening?

Enhancing alcohol screening and brief intervention among people receiving opioid agonist treatment: Qualitative study in primary care

New Paper Out Now

Although very common, excessive drinking by people who also use other drugs is rarely studied by scientists. The purpose of this study was to find out patient’s and clinicians’ opinions about addressing this issue. All of them took part in a study called PINTA – Psychosocial interventions for problem alcohol use among problem drug users.

photocredit: emerald

Doctors reported obstacles to addressing heavy drinking and overlooking and underestimating this problem in this population.

Patients revealed that their drinking was rarely spoken about and feared that their methadone would be withheld.

Read the full article in the latest issue of the Drugs and Alcohol Today:

See also my previous posts about the PINTA study:

New paper out now: Psychosocial Interventions for Alcohol use among problem drug users


Beg, steel or borrow: getting physicians to recruit patients in clinical trials

Addiction Medicine Education for Healthcare Improvement Initiatives: New Paper out Now


Honor pot: testing doctors’ drug counselling skills in a new pilot study in Ireland

Fidelity questions

Why Empirically Supported Psychosocial Treatments Are Important for Drug Users? New research project