N/A N=979 Randomized Single-blind Prevention

Change the Cycle: An RCT to Prevent Injection Initiation

Substance Abuse, Intravenous · HIV · Heroin Dependence · Opioid Dependence · Cocaine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT02774954 ↗

Enrolled (actual)

979

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: People Initiated Into Injection Drug Use — 2.05; 3.26 People initiated — p=0.35

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Change the Cycle (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Southern California
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY People Initiated Into Injection Drug Use	2.05; 3.26	0.35
PRIMARY Number of Request to Initiate Someone Into Drug Injection	6.42; 4.06	0.35

Summary

The study will test the efficacy of a hour long, one-on-one, active listening counseling session (called Change the Cycle or CTC) aimed at reducing behaviors among active people who inject drugs (PWID) that research has found to facilitate uptake of injection drug use among non-injectors. The study will involve ~1,100 PWID who will be randomized to CTC or an equal attention control intervention on improving nutrition. Participants will be recruited in Los Angeles and San Francisco, California and followed up at 6 and 12 months to determine changes in direct and indirect facilitation of injection initiation among non-injectors.

Eligibility Criteria

Inclusion Criteria

Self-reported Injection an illicit drug in the last 30 days,
visible evidence of injection such as track mark or stigmata,
at least 18 years of age

Exclusion Criteria

Under 18 years of age,
no self-reported drug injection in the last 30 days,
no physical evidence of recent drug injection.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02774954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.