Subutex and Placebo

What research ethics questions arise when giving a placebo to heroin addicts?

[The following text is an example or "case", which can serve as a starting point for reflection and discussion. Some examples may be based on real events, while others are fictional representations.] 

There is a long waiting period and strict conditions for inclusion in opioid substitution therapy (OST) for long-term heroin addiction. You wish to conduct a project where you will examine the effect of offering substitution treatment with buprenorphine (Subutex) to those who want to quit heroin but either are on a waiting list or do not meet the criteria for inclusion in OST. You plan to conduct the study as a randomized double-blind trial (RCT). This means that half of the participants will randomly receive a placebo. To prevent the placebo group from immediately noticing they are receiving a placebo, participants in this group will be given Subutex in a tapering dose down to zero over the course of the first two weeks. You intend to follow the participants for one year.

Discuss the research ethics questions that such a study raises.

 

Note: This is a translation of the Norwegian original text by Johanne Svanes Oskarsen.