PHAST: Physical Activity in Substitution Therapy

Status Completed

Clinical Trial Summary

The aim is to examine the effect of exercise (EX) training on individuals currently receiving ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) - for their opiate dependence. Main outcome variables will be: cardiovascular fitness; consumption of substances (e.g. "street heroin", cocaine, cannabis, alcohol, cigarettes) other than prescribed ST or other prescribed medications; substance craving; blood pressure; lung function; resting pulse; social interaction; self-control capacity; objective and subjective sleep; cortisol levels; quality adjusted life years (QALYs); depression; mood. Covariates are current substitution dose and psychiatric diagnoses.

Clinical Trial Description

The investigators aim is to carry out a randomized controlled trial comparing exercise training group and a control group of patients receiving substitution therapy (ST). The specific goals of the study are:

1. To understand the exercise preferences, barriers to participation, motivation, experiences and attitudes regarding exercise training in patients under ST.

2. To examine whether a 12-week exercise programme affects the mental health, subjective and objective sleep, quality of life, self-control capacity, substance craving, hair cortisol levels, secondary consumption, cardiovascular fitness, blood pressure, lung function, resting pulse, and social interaction in patients receiving ST.

3. To compare the effects of the EX and control conditions on the above-mentioned outcome variables.

4. To examine to what degree the covariates of heroin substitution dose and psychiatric comorbidities affect outcome variables.

5. To explore to what extent objective variables (cardiovascular fitness, pulse, blood pressure, lung function, cortisol, objective sleep-EEG-parameters) and subjective-psychological dimensions (subjective sleep, social interaction, symptoms of depression and anxiety, self-control, substance craving) are interrelated. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Substance-related Disorders

Clinical Trial Details

NCT number	NCT02309021
Study type	Interventional
Source	University Hospital, Basel, Switzerland
Contact
Status	Completed
Phase	N/A
Start date	November 2014
Completion date	November 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05054738` - CRP and S&A for Inpatient Veterans	N/A
Recruiting	`NCT04157062` - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder	N/A
Completed	`NCT02233738` - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services	N/A
Enrolling by invitation	`NCT06084221` - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems	N/A
Completed	`NCT02907944` - Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation	N/A
Completed	`NCT02829970` - Helping College Students With ADHD Lead Healthier Lifestyles	N/A
Completed	`NCT02570360` - Exercise and Treatment-as-usual in Substance Use Treatment Outcomes	N/A
Completed	`NCT02125539` - Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment	Phase 2
Completed	`NCT02945371` - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life	N/A
Completed	`NCT02715557` - Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers	N/A
Completed	`NCT02388243` - The Computer-based Drug and Alcohol Training Assessment in Kenya	N/A
Completed	`NCT01633138` - Performance-based Reinforcement to Enhance Cognitive Remediation Therapy	N/A
Completed	`NCT02218970` - The Effect of Muscular Strength Training in Patients With Drug Addiction	N/A
Completed	`NCT01591239` - Home-Based Program to Help Parents of Drug Abusing Adolescents	N/A
Active, not recruiting	`NCT01539525` - Screening to Augment Referral to Treatment- Project START	Phase 2
Withdrawn	`NCT01224002` - A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine	N/A
Withdrawn	`NCT00891631` - Primary Care iSBIRT to Reduce Serious Teen Health Risks	Phase 1/Phase 2
Completed	`NCT00970372` - Dual-Diagnosis and Compulsory Treatment	N/A
Completed	`NCT01365247` - Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)	N/A
Completed	`NCT00419029` - Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PHAST: Physical Activity in Substitution Therapy — PHAST

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms