To investigate:- Whether a harm reduction strategy with education and counseling is effective in reducing the use of AAS by amateur athletes. - The harm reduction potential of an additional online consultation with a well-known fitness expert. -…
Source
Brief title
Condition
- Other condition
- Hepatic and hepatobiliary disorders
- Respiratory disorders NEC
Synonym
Health condition
middelenmisbruik, afhankelijkheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• The effect of a harm reduction strategy on the duration of exposure to AAS by
amateur athletes in a 12 month study period.
• The effect of a one-time online consultation about diet and training regimens
on the duration of exposure to AAS in a 12 month study period.
• The extent to which providing a harm reduction intervention leads to a
different amount of new users of AAS.
• The prevalence of obstructive sleep apnea syndrome during AAS use.
• The prevalence of non-alcoholic fatty liver disease during AAS use.
Secondary outcome
• The effect of a harm reduction strategy on the duration of growth hormone use
and the number of times post-cycle therapy is employed in a 12 month study
period.
• The extent to which the different user typologies predict the effectiveness
of the harm reduction strategy..
• The incidence of serious adverse events during or after AAS use.
Background summary
The prevalence of anabolic androgenic steroid (AAS) use among men frequenting
gyms is 4-6%. In the Netherlands an estimated 20.000 men use AAS. There is a
lack of data about the negative health effects of AAS use, but current
literature indicates that AAS increase cardiovascular risk, and disrupt
endogenous testosterone production and spermatogenesis. The Center of Expertise
for Anabolic Steroids in the Spaarne Gasthuis and Elisabeth-TweeSteden hospital
in the Netherlands aims to provide more insight into the harmfulness of AAS
use. In addition, medical care is provided to patients that experience health
issues resulting from previous AAS use. Up till now, there is no primary or
secondary prevention that has proved effective in reducing harm caused by AAS.
Possibly there may be a role for medical experts in the field of AAS. As a harm
reduction strategy they could provide users with advice and counseling.
Study objective
To investigate:
- Whether a harm reduction strategy with education and counseling is effective
in reducing the use of AAS by amateur athletes.
- The harm reduction potential of an additional online consultation with a
well-known fitness expert.
- Whether offering the entire harm reduction draws in more (new) users of AAS
is also examined.
- The occurrence of sleep apneas and the obstructive sleep apnea syndrome
during AAS use.
- The occurrence of non-alcoholic fatty liver disease during AAS use.
Study design
The HARNAS trial (harm reduction in anabolic androgenic steroid use) is a
clinical intervention study with historical control group. A hundred male
amateur athletes of at least 18 years old intending to start a self-composed
cycle of AAS are included for participation. Study subjects will receive
education and counseling aiming primarily to shorten the intended cycle
duration, reduce the number of androgen types used, and use less other PIEDs.
Through 1:1 randomization subjects are assigned to a one-time online
consultation with a well-known fitness expert to receive information about diet
and training regimens. Before (T0), during (T1) and after (T2) the cycle
medical investigation take place (blood analysis, electrocardiography) and the
results are discussed with the participants in an attempt to further limit
their AAS use. At least 30 and at most 50 subjects of the entire cohort will
also be analyzed for the occurrence of sleep apnea at those moments with the
use of the WatchPAT. About 1 year after inclusion a last follow-up moment (T3)
takes place to document whether a subject started a new cycle after finishing
the first.
Intervention
See 'study design'.
Study burden and risks
See paragraph E9.
Dr. Deelenlaan 5
Tilburg 5042AD
NL
Dr. Deelenlaan 5
Tilburg 5042AD
NL
Listed location countries
Age
Inclusion criteria
• Men of at least 18 years old.
• The subjects intents to start an androgen cycle within 2 weeks after
enrollment.
• The planned cycle has an average weekly dose >250 mg and duration >6 weeks.
Exclusion criteria
• The use of AAS in the 3 months prior to enrollment (except for TRT <250
mg/week).
• When in the last 6 months:
1) A new somatic or psychiatric illness was diagnosed.
2) A medication for chronic illness was started or changed.
3) A (non-traumatic) hospital admission occured (or psychiatric ward
admission).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL77191.028.21 |