Prevalence and profile of pregabalin abuse in patients visiting a drug de-addiction center

Abstract

Background:

Pregabalin, a Gamma aminobutyric acid (GABA) analog, is widely prescribed for neuropathic pain, anxiety disorders, and epilepsy. However, its potential for misuse has raised significant public health concerns globally. The misuse of pregabalin is increasingly reported in our part of the world, where substance abuse is already a growing issue due to social, political, and psychological vulnerabilities.

Aim:

This study aimed to assess the profile and prevalence of pregabalin abuse among patients visiting a de-addiction center in Kashmir.

Material and Methods:

A cross-sectional study was conducted among 43 patients admitted to a de-addiction center in Kashmir over 3 months. Data on sociodemographics, substance use patterns, and reasons for misuse were collected using a semi-structured questionnaire.

Results:

Out of the 43 patients, 19 (44.2%) reported pregabalin as the primary substance abused, while 24 (55.8%) reported it as a secondary substance. Males constituted 93% of the sample, with the majority (72.1%) aged 18–35 years. Polysubstance use was observed in 65% of patients, primarily involving opioids (51.2%) and synthetic drugs such as tramadol and codeine (39.5%). Common reasons for abuse included anxiety relief (55.8%), pain relief (37.2%), and recreational use (30.2%).

Conclusion:

Pregabalin abuse is an emerging issue in Kashmir, often associated with polysubstance use and psychiatric comorbidities. Urgent steps are needed to regulate its availability, raise awareness regarding its abuse potential, and improve access to mental health services in the region.

Drug abuse is a rising public health problem worldwide with important medical, psychological, and social implications. Over the past few years, the abuse of prescribed drugs has become an increasing concern, especially among vulnerable individuals. Among these drugs, pregabalin, a structural GABA analog, has raised growing interest because of its misuse, dependence, and addiction potential.[1] Pregabalin is commonly used in the management of neuropathic pain, epilepsy, and generalized anxiety disorder (GAD). The drug works through the binding of the α2δ subunit of the voltage-gated calcium channels, ultimately preventing the release of excitatory neurotransmitters, including glutamate, norepinephrine, and substance P.[2] While pregabalin does not exert a direct effect on GABA receptors, its GABA-mimetic action is responsible for its anxiolytic, sedative, and euphoric properties and thus has the highest appeal for abuse.[3] Pregabalin abuse tends to be dominated by the intake of large amounts (3–20 times the therapeutic dosage), producing feelings of euphoria, sedation, dissociation, and hallucinations.[4] High oral bioavailability (≥90%) and immediate onset of activity also add to its attractiveness in users aiming to achieve pleasure-related effects.[5] Across the world, abuse of pregabalin has been reported on the rise in Europe, the Middle East, and South Asia, particularly in individuals with prior history of opioid addiction or polysubstance use.[6] Pregabalin abuse presents serious clinical problems because of its withdrawal effects, such as anxiety, irritability, insomnia, nausea, and tremors.[4] A UK-based online survey among 1500 persons from a consumer panel showed eight (0.5%) patients reporting misuse of pregabalin.[7] An increasing evidence base indicates that pregabalin abuse is more prevalent in groups of individuals with psychiatric comorbidities, opioid addiction, or a history of substance use.[2] A US-based self-report questionnaire in patients admitted to a public detoxification program showed that among 196 patients, 162 were admitted due to opioid dependency and 7% of them reported having misused pregabalin.[7] In addition, polysubstance use with pregabalin enhances the risk of overdose, respiratory depression, and death.[6]

In India, the free availability of pregabalin without a prescription and lax regulatory measures have added to its increasing abuse. Kashmir, in particular, has seen a transition in substance use patterns in recent years, with rising incidents of abuse of prescription drugs along with classical opioids. Factors such as high unemployment rates, socioeconomic hardships, mental health issues, and lack of awareness regarding prescription drug risks have further fueled this trend.[8]

As a result of the increasing abuse of pregabalin in India, the government has made attempts to regulate its sale and distribution. Pregabalin and its preparations are being contemplated for listing under Schedule H1 to limit their access and control abuse.[9] The step is being taken to have more stringent regulation of prescriptions and stop over-the-counter sales of these drugs. Regulatory actions at the state level have also been taken. The Telangana Drugs Control Administration has released a public notice requiring pregabalin formulations to be sold only on the prescription of a registered medical practitioner. Retail shops and hospital-based pharmacies are asked to maintain details of all pregabalin sales in a prescription register.[10] Despite the growing prevalence of pregabalin abuse in Kashmir, there is a paucity of research exploring its patterns, associated risk factors, and clinical implications. The lack of systematic data limits the development of targeted prevention and intervention strategies. Understanding the sociodemographic characteristics, substance use patterns, and clinical correlates of pregabalin misuse is crucial for designing evidence-based interventions and policy measures. The current study aimed to assess the profile and prevalence of pregabalin abuse among patients visiting a de-addiction center in Kashmir.

MATERIALS AND METHODS

It was a cross-sectional study conducted at the de-addiction center of Government Medical College, Srinagar over 3 months (December 2024–February 2025). A total of 43 patients with pregabalin abuse were seen during these 3 months. Written informed consent was taken from all the participants. The inclusion criteria included participants giving informed consent to participate, age 18–45 years, and history of pregabalin abuse (self-reported or clinician-diagnosed). The exclusion criteria included those patients who had severe illness affecting their ability to participate in the study and non-consenting individuals.

Pregabalin abuse was defined as use without a prescription, in a way other than prescribed, or for the experience or feelings elicited.[11]

The objectives of the study were made clear to the participants. Participants were informed that the collected data will be used only for research purposes, and their identity will remain confidential. Data were collected using a semi-structured questionnaire through face-to-face interviews. The questionnaire was designed to collect the following information: sociodemographic profile (age, gender, residence, employment status), pattern of pregabalin abuse (primary or secondary substance), duration and route of use, reasons for abuse, polysubstance use, psychiatric comorbidities, and withdrawal symptoms. Urinary drug screen kits were used to ascertain current drug use besides pregabalin. International Classification of Diseases (ICD-11) criteria were used for ascertaining dependence patterns. The presence of psychiatric comorbidity was assessed using the Mini-International Neuropsychiatric Interview 7.0.2. The study was done in accordance with the Declaration of Helsinki.

Statistical analysis

The data were entered into an Excel sheet and tabulated and then analyzed using SPSS software version 20.0 (IBM Corporation, Armonk, New York, USA). Categorical variables were summarized as frequency and percentage. Continuous variables were summarized as mean and standard deviation. Data are presented in Tables 1 and 2.

Table 1.

Sociodemographic characteristics of pregabalin Users (n=43)

Variable	Category	Frequency (%)
Gender	Male	40 (93.0)
	Female	3 (7.0)
Age Group	18–25 years	31 (72.1)
	26–35 years	8 (18.6)
	36–45 years	4 (9.3)
Background	Rural	30 (69.8)
	Urban	13 (30.2)
Employment Status	Unemployed	24 (55.8)
	Employed	19 (44.2)
Marital Status	Married	25 (58.1)
	Unmarried	18 (41.9)
Education Level	Illiterate	24 (55.8)
	Up to 10th standard	10 (23.3)
	High school/Diploma	5 (11.6)
	Graduate and above	4 (9.3)
Psychiatric Comorbidity	Depression	10 (23.3)
	Bipolar Affective Disorder	5 (11.6)
	Generalized Anxiety Disorder	3 (7.0)
	Personality issues	3 (7.0)
	None	22 (51.2)
Family History of Substance Use	Yes	15 (34.9)
	No	28 (65.1)

Table 2.

Substance use patterns among pregabalin abusers

Parameter	Frequency (%)
Pregabalin as Primary Substance	19 (44.2)
Pregabalin as Secondary Substance	24 (55.8)
Route of Use (Oral)	43 (100)
Daily Use (>300 mg/day)	26 (60.5)
Mean Daily Dosage (mg)±SD	610±115 mg
Duration of Use (>6 months)	24 (55.8)
Mean Duration of Use (months)±SD	9.2±3.8 months
Self-Medication Without Prescription	34 (79.1)
Source of Drug (Pharmacy Without Prescription)	30 (69.8)
Reasons for Pregabalin Abuse
Anxiety Relief	24 (55.8)
Pain Management	16 (37.2)
Recreational Use	13 (30.2)
Sleep Aid	10 (23.3)
Peer Influence	7 (16.3)
Concurrent Opioid Use with Pregabalin
Opioids	22 (51.2)
Synthetic Drugs (Tramadol, Codeine)	17 (39.5)
Cannabis	11 (25.6)
Benzodiazepines	9 (20.9)
Alcohol	7 (16.3)

RESULTS

From December 2024 to February 2025, a total of 21,942 patients (21,667 old patients and 379 new patients) attended our de-addiction outpatient department, out of which 19,442 patients had opioid dependence. A total of 43 cases of pregabalin use were identified in this period. The prevalence of pregabalin use among the new patients was 11.3%.

The study cohort comprised predominantly male participants, 40 (93.0%), with females making up only 7.0% (3) of the sample. Most users, 31 (72.1%) were within the 18–25 years age group. A significant proportion of users (69.8%) came from rural backgrounds. Regarding employment status, the majority (55.8%) were unemployed. Table 1 depicts the sociodemographic profile of pregabalin abusers. The oral route was universally reported in 100% of users. Table 2 depicts the substance use patterns of pregabalin abusers.

DISCUSSION

The present study is the first of its kind to highlight the rising trend of pregabalin abuse among patients attending a de-addiction center in Kashmir. Our findings align with global and regional reports, emphasizing the growing misuse of prescription medications, particularly among vulnerable populations with limited healthcare access and socioeconomic hardships.[4,12]

Our study indicates that young males (93%) from rural backgrounds (69.8%), who are unemployed (55.8%) and illiterate (55.8%) [Table 1], constitute the majority of pregabalin abusers. This aligns with studies from India and the Middle East, which report that young males with low education levels and poor employment prospects are at higher risk for prescription drug abuse.[13,14] Lower educational attainment has been linked to a lack of awareness regarding the risks of self-medication, leading to the unregulated use of drugs such as pregabalin.[15]

The rural predominance (69.8%) suggests that factors such as lack of access to mental health services, unemployment, and social stressors may contribute to substance abuse in these regions. Similar findings have been reported in North India, where rural populations exhibited higher rates of pregabalin dependence due to easy availability from unregulated pharmacies and the absence of stringent prescription policies.[16] Economic instability has been consistently linked to substance use disorders, as unemployed individuals often experience increased psychological distress and reduced access to healthcare.[12] In addition, such individuals resort to self-medication to manage psychiatric symptoms or withdrawal from other substances.[17] Research from Punjab indicates that economic vulnerability plays a crucial role in drug dependence, with unemployed individuals being more likely to engage in polysubstance use, including opioids and benzodiazepines, in combination with pregabalin.[18]

A striking finding of our study was the high mean daily dosage of pregabalin (610 ± 115 mg), with 60.5% of users exceeding 300 mg/day. This is considerably higher than the recommended therapeutic dose for conditions such as neuropathic pain or GAD (150–300 mg/day).[19] Studies from Sweden and the UK have highlighted that excessive doses of pregabalin, especially above 600 mg/day, significantly increase the risk of dependence, withdrawal symptoms, and severe adverse effects, including respiratory depression when combined with opioids.[5,12]

More than half (55.8%) of our sample had been using pregabalin for over 6 months, with an average duration of use of 9.2 ± 3.8 months. Prolonged use has been linked to tolerance, leading individuals to escalate their doses to achieve the desired effects, particularly euphoria or sedation.[20] This pattern of dose escalation has been reported in studies from Europe, where long-term pregabalin users often develop dependence requiring medical intervention for withdrawal management.[21]

Our study found that pregabalin is primarily abused for anxiety relief (55.8%), pain management (37.2%), and recreational use (30.2%) [Table 2]. This is consistent with global studies, where pregabalin is often abused for its euphoric and anxiolytic effects.[22] A qualitative study in Belgium also reported widespread pregabalin abuse among individuals with poor access to mental health care.[23] Furthermore, peer influence (16.3%) also contributes to abuse. Self-medication without prescription (79.1%) and easy availability from pharmacies (69.8%) indicate major regulatory loopholes, similar to trends reported in India and the Middle East.[14]

Our findings highlight significant polysubstance use, with opioids (51.2%) and synthetic drugs such as tramadol and codeine (39.5%) being the most frequently co-used substances [Table 2]. This is particularly concerning as studies from the UK and Belgium have demonstrated that pregabalin, when combined with opioids, increases the risk of fatal overdose due to its potentiating effects on respiratory depression.[12,23] Opioid users frequently abuse pregabalin to enhance opioid effects or manage withdrawal symptoms, further complicating treatment outcomes.[24]

Given the high prevalence of polysubstance use, our findings support the need for specialized de-addiction programs tailored to patients with multiple substance dependencies. Integrated treatment models incorporating pharmacological and psychosocial interventions have been suggested as the most effective approach to managing complex cases of pregabalin dependence.

The prevalence of pregabalin abuse in our study participants was 11.3%. This is alarming and denotes a shift from the use of usual opioids to prescription drugs, especially in times of shortage of the usual opioids. Despite increasing reports of pregabalin abuse, it remains an uncontrolled substance under India’s NDPS Act, allowing over-the-counter sales without regulatory oversight.[13] In contrast, the UK reclassified pregabalin as a class C controlled substance to mitigate its abuse, leading to tighter legal controls over its prescribing.[25] Similar policy reforms, including stricter prescription regulations, pharmacist training programs, and prescription drug monitoring systems (PDMS), are urgently needed in India to curb pregabalin abuse. Public awareness campaigns and routine screening in de-addiction centers should also be implemented to identify at-risk individuals early. Increasing public knowledge about prescription drug risks, combined with regulatory enforcement, can significantly reduce non-medical use.[14]

Limitations

The study included only 43 participants, which may not be representative of the broader population affected by pregabalin abuse. A larger sample could provide more generalizable results. As the study was conducted at a single de-addiction center in Kashmir, the findings may not reflect the trends in the community. Many variables, including substance use patterns and reasons for abuse, were based on self-reports. This introduces the risk of recall bias and underreporting due to social desirability.

CONCLUSION

Pregabalin abuse is an emerging public health concern in Kashmir, predominantly affecting young, unemployed males with psychiatric comorbidities. High-dose use, polysubstance dependence, and easy pharmacy access necessitate urgent interventions at the community level. A combination of stricter prescription regulations, improved mental health services, and employment programs could play a crucial role in mitigating this growing problem.

Authors contributions

Concept, design, and literature search: SM and SP; Data acquisition: SM; Data analysis: MZ; Manuscript preparation: SM, MZ, YH, and AH; Manuscript editing and manuscript review: IR and HH.

Ethical clearance

The study was cleared by the Institutional Ethical Committee of Government Medical College Srinagar (IRBGMC-SGR/Psy/889. dated March 11, 2025).

Data availability

Data can be made available on reasonable request.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.