ATLAS4dependence

Individuals who are dependent on amphetamines or methamphetamines have an increased disease burden and several health challenges. Infections, cardiovascular diseases, and psychological symptoms are just a few of these, in addition to an increased risk of death and reduced quality of life.

Effective and evidence-based treatment methods for amphetamine dependence are currently lacking. There is therefore a significant need to conduct studies that investigate various treatment methods, and this study aims to contribute to that.

The study investigates whether treatment with dextroamphetamine (DXA) can help individuals with long-term dependence on illegal stimulants. We wish to include both patients receiving medication-assisted rehabilitation (LAR) and individuals who do not receive such support.

The study will focus on the efficacy and safety of such treatment.

The study is a double-blind, placebo-controlled multicentre study. This means:

• Participants from several locations in Norway will be randomly assigned to two groups.
• One group will receive dextroamphetamine (DXA) for 12 weeks.
• The other group will receive a placebo (PBO) for 12 weeks.
• Neither the participants, the clinicians, nor the researchers will know who receives what.

Participants will be randomised to one of two possible study arms:

• DXA – participants will receive dextroamphetamine for 12 weeks
• PBO – participants will receive a placebo for 12 weeks

Follow-up in the study:

• Interviews with the study nurse before starting, twice during the study, and once after 12 weeks.
• Weekly follow-up by healthcare personnel.
• Urine tests once a month under supervision.
• Saliva, hair, and blood samples will be taken during the study.

All participants will receive good support from the study staff.

Study design

Photo: Norcats

Schematic timeline of the study design in the A4D study.

The explanation can be found just below.