Clinical trial NCT04513756: Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users
Official title: A Randomized Controlled Trial (RCT) to Asses the Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cannabis Dependence
Lead sponsor: International Islamic University, Islamabad
Sponsor class: OTHER
Collaborators: name: Pakistan Institute of Living and Learning
First posted: 2020-08-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Substance abuse is not a new phenomenon in Pakistan. Its prevalence is increasing day by day due to multi-factorial reasons including psychological, cultural, biological, environmental, social and personal factors. Recent statistics shows an alarming increase in the use of substance. The last survey conducted indicates there are 3.6 million substance users in Pakistan and 3.6 percent among them are cannabis users. Furthermore, cannabis is found to be the most prevalent abused drug with adverse impact on the mental health among university students in Pakistan. However, there is a dearth of literature which could indicate a well-established treatment policy with proven efficacy model available in Pakistan. This study aims to investigate the efficacy of Community Reinforcement Approach (CRA) as evidence based remedy for Cannabis Users. The study is designed in a Randomized Controlled Trial (RCT) consisting of groups: Active Treatment (AT; with nine sessions of CRA intervention) and Treatment as Usual (TAU; routine treatment). After screening and baseline, participants will be assigned to the either Active Treatment group or Treatment As Usual group. Participants in both groups will be assessed on completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up). The primary outcome measure will be the frequency of usage, abstinence period and quantity of cannabis by using Timeline Follow Back Interview. The duration of the study is two and half years


Eligibility criteria: Inclusion Criteria:

1. Aged 18-30.
2. Current, regular cannabis use, defined as the use of any cannabis product at least twice per week over the course of the past 12 months.
3. Participant able to provide informed consent and willing to participate in the study.

Exclusion Criteria:

1. ICD-11 dependence (in the previous 12 months) on alcohol or any other illicit drug (apart from cannabis) with symptoms of withdrawal, tolerance or craving.
2. Current use of opiate substitution or sedative-hypnotic medication.
3. Having been treated for cannabis use problems with any other treatment within the previous three months.
4. Participant with lifetime psychotic disorder.
5. Participants with moderate, severe and extremely severe scores on (DASS-21) will be excluded. Severe learning disability or a pervasive developmental disorder.
6. Signs of severe non-cannabis-related intoxication.

Primary outcomes:
measure: Time Line Follow-Back Interview (Assessing Change)
timeFrame: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
measure: The Severity of Dependence Scale (Assessing Change)
timeFrame: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
Secondary outcomes:
measure: Depression Stress and Anxiety Questionnaire
timeFrame: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
measure: EQ-5D-5L
timeFrame: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Psychological Services Clinic, Medical Center, International Islamic University
state: Federal Capital
city: Islamabad
country: Pakistan
facility: Research Office, Department of Psychology, International Islamic University Islamabad
state: Federal
Study officials:
affiliation: International Islamic University, Islamabad
name: Muhammad Tahir Khalily, PhD
role: PRINCIPAL_INVESTIGATOR
References: